Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2021 | Month : July | Volume : 15 | Issue : 7 | Page : NC01 - NC05 Full Version

Evaluation of Intraocular Pressure Changes with Topical Dexamethasone 0.1%, Prednisolone 1% and Difluprednate 0.05% Postcataract Surgery- A Randomised Clinical Trial


Published: July 1, 2021 | DOI: https://doi.org/10.7860/JCDR/2021/47085.15071
Sachit Mahajan, Sanjay Kai, Sadaf Choudhary, Kiran Bala, Bhavna Sahni

1. Junior Resident, Upgraded Department of Ophthalmology, Government Medical College, Jammu and Kashmir, India. 2. Professor, Upgraded Department of Ophthalmology, Government Medical College, Jammu and Kashmir, India. 3. Junior Resident, Upgraded Department of Ophthalmology, Government Medical College, Jammu and Kashmir, India. 4. Assistant Professor, Postgraduate Department of Community Medicine, Government Medical College, Jammu and Kashmir, India. 5. Assistant Professor, Postgraduate Department of Community Medicine, Government Medical College, Jammu and Kashmir, India.

Correspondence Address :
Bhavna Sahni,
473, Nitco Lane, Talab Tillo, Jammu-180002, Jammu and Kashmir, India.
E-mail: bhavnasahni@gmail.com

Abstract

Introduction: Topical corticosteroids are most commonly used for the control of postoperative inflammation after cataract surgery. Topical steroids may cause increase in Intraocular Pressure (IOP) which, if left untreated may lead to progressive optic nerve damage and glaucomatous field defects.

Aim: To compare the ocular hypertensive response of three commonly used corticosteroids in an effort to generate evidence for managing postcataract surgery inflammation more effectively.

Materials and Methods: This randomised clinical trial was carried out for a period of one year from November 2018 to October 2019, among 150 patients undergoing cataract surgery. Patients were divided into three groups. Group A-50 patients received topical dexamethasone 0.1%, Group B-50 patients received topical prednisolone 1% and Group C-50 patients received topical difluprednate 0.05% four times a day for six weeks after cataract surgery. Postoperative IOP was recorded preoperatively, on first postoperative day and at the end of first week, third week and sixth week with non contact tonometer and statistical significance was assessed with the help of repeated measures mixed model Analysis of Variance (ANOVA).

Results: The mean age of the patients was 64.4±9.39 years, 48% were males and 52% patients were females. Mean IOP in the three drug groups was not statistically significant at 1st week, 3rd week and at 6th week after cataract surgery. Two patients belonging to difluprednate group at the end of 1st week and one patient at the end of 3rd week after cataract surgery developed significant rise in IOP (>31 mmHg).

Conclusion: It can be concluded that all three steroids were equally safe and did not cause any statistically significant rise in IOP over six-week postoperative period. However, higher values were noted in difluprednate group at the end of first and third week after cataract surgery.

Keywords

Ocular hypertension, Phacoemulsification, Steroids, Tonometry

Cataract surgery is the most common ophthalmological surgical procedure performed on geriatric age group. Surgical trauma to the eye initiates an inflammatory reaction, which results in recruitment of neutrophils and macrophages to the site of trauma and release of arachidonic acid, which inturn causes production of prostaglandins (1).

Postoperative surgical inflammation after cataract surgery may be associated with complications like corneal oedema, increase in IOP, posterior synechiae formation, posterior capsular opacification and cystoid macular oedema (2). Topical corticosteroids are most commonly used for the control of postoperative inflammation after cataract surgery (3). Corticosteroids mediate their anti-inflammatory actions by acting on glucocorticoid receptors. At the histological level, corticosteroids inhibit capillary dilation, cellular infiltration, proliferation of fibroblasts, collagen deposition, and eventual scar formation. Corticosteroids stabilise intracellular and extracellular membranes and increase the synthesis of lipocortins. Lipocortins, inturn inhibit phospholipase A2, an enzyme which converts phospholipids to arachidonic acid, thereby, preventing the release of its metabolites, including prostaglandins (4).

Topical steroids can produce side-effects, like increase in IOP, cataract formation (in phakic eyes) and lowered resistance to infection (5),(6),(7). Increase in IOP, if left untreated may lead to progressive optic nerve damage and glaucomatous field defects, leading to corticosteroid induced glaucoma. Corticosteroids increase IOP by several mechanisms (8). Corticosteroids alter trabecular meshwork cell morphology by causing increase in nuclear size and Deoxyribonucleic Acid (DNA) content. FKBP51, FK506-binding immunophyllin, mediates nuclear transport of human glucocorticoid Receptor, Glucocorticoid receptor beta (GRbeta), causing increased glucocorticoid responsiveness. Corticosteroids stabilise the lysosomal membrane, which leads to accumulation of polymerised glycosaminoglycans, which become hydrated, increasing the resistance to aqueous outflow. Corticosteroids inhibit the phagocytic activity of trabecular meshwork endothelial cells, allowing for the debris to accumulate in meshwork and act as a barrier to outflow of aqueous humour. Myocillin gene, initially referred to as trabecular meshwork inducible- glucocorticoid response or Trabecular Meshwork Inducible Glucocorticoid Response (TIGR) gene product, a 55kDa protein, is induced after exposure to corticosteroids. This gene causes decreased aqueous humour outflow and increase in IOP (8).

Dexamethasone, prednisolone, and flourometholone are early generation corticosteroids and rimexolone, difluprednate, and loteprednol etabonate are relatively newer corticosteroids used for control of postoperative inflammation. Dexamethasone is available as phosphate derivative in the form of a 0.1% ophthalmic suspension or solution. Prednisolone is a synthetic analog of hydrocortisone. It is formulated as an acetate and a phosphate (9). Difluprednate is a prednisolone acetate derivative that is augmented by two fluorinations at carbons 6 and 9, a butyrate group at carbon 17 and an acetic acid group at carbon 21 (9).

Keeping in view the IOP raising potential of various steroids which are routinely used for the management of postcataract surgery inflammation, this study was conceptualised to compare the ocular hypertensive response to three commonly used corticosteroids in an effort to generate evidence for managing postcataract surgery inflammation more effectively.

Material and Methods

The present randomised clinical trial was conducted for a period of one year from November 2018 to October 2019 after obtaining ethical clearance from Institutional Ethics Committee vide letter number IEC/GMC/2019/800 in the Ophthalmology Department of Government Medical College, Jammu and Kashmir, India.

This study included 150 patients undergoing cataract surgery with Posterior Chamber Intraocular Lens Implantation (PCIOL). A written informed consent was taken from all the study participants after explaining the purpose of the study.

Inclusion criteria: Patients above 40 years of age, diagnosed to have senile cataract and having cortical cataract and nuclear sclerosis grade 1, 2, 3 cataract on Lens Opacities Classification System III (LOCS III) (10) were included in the study.

Exclusion criteria: Patients below 40 years of age and who had glaucoma, patients with complicated cataracts (traumatic cataracts, radiation induced cataracts, ubluxated lens) and who had grade 4 and 5 nuclear sclerosis on Lens Opacities Classification System III (LOCS III) were excluded. Patients with pseudoexfoliation syndrome and lens related glaucoma were excluded. Who had pigment dispersion syndrome, diabetes mellitus, myopia (>5D) and patients already on corticosteroid treatment were excluded. Patients with fundus pathologies having influence on IOP like central retinal artery occlusion, central retinal vein occlusion, branch retinal artery occlusion, branch retinal vein occlusion, retinal detachment and who were developing intraoperative complications during cataract surgery were also excluded.

Sample size calculation: A sample size of 150 was calculated using effect size of 0.6 and these patients were divided into three groups (A, B and C) of 50 patients each using 1:1:1 block permuted randomisation using online software sealed envelope (Table/Fig 1).

Detailed history regarding ocular and systemic diseases were noted from each patient. IOP was recorded with SHIN NIPPON Non Contact Tonometer (NCT)-200 by single investigator at the same time of the day, in the morning.

All patients underwent cataract surgery with PCIOL implantation. All the surgeries were performed by a single surgeon. All the patients were included only once in the study. IOP was recorded on first day after cataract surgery before installation of any drug by a single investigator at same time of the day by NCT. Group A patients received topical dexamethasone 0.1%, Group B patients received topical prednisolone 1% and Group C patients received topical difluprednate 0.05%. Each drug was given four times a day for six weeks after cataract surgery. IOP was recorded by NCT, preoperatively, postoperatively- on first postoperative day and then at the end of 1st week, 3rd week and 6th week. Any patient, who developed rise in IOP >21 mmHg after two readings taken 24 hours apart was started on anti-glaucoma medications and the medications continued till IOP was <20 mmHg on two readings taken 24 hours apart after stopping the drugs. Patients who developed rise in IOP in response to topical steroids continued follow-up for six weeks.

Statistical Analysis

All the data were entered into Microsoft Excel and analysed with the help of IBM Statistical Package for the Social Sciences (SPSS) version 22.0. Mean IOP (±SD) was estimated for all the three groups and statistical significance assessed with the help of repeated measures mixed model Analysis of Variance (ANOVA). Post-hoc comparisons were adjusted by the Bonferroni method. A p-value <0.05 was considered as statistically significant. All p-values used were two-tailed.

Results

The mean age in this study was 64.4±9.39 years. Majority of the patients belonged to the age group of 61-70 years. As seen in (Table/Fig 2), out of 150 patients, 52% were females and 48% patients were males. The right eye was operated in majority of patients i.e., 52.7% and left eye in 47.3%.

Mean IOP readings with three drugs over a six-week postoperative period is shown in (Table/Fig 3). Mean IOP was higher in difluprednate group at 1st, 3rd and 6th postoperative week which was not statistically significant.

Bonferroni post-hoc tests comparing different time intervals revealed a significant difference in the mean IOP between that measured preoperatively and at first day of surgery (p=0.03) and also between first postoperative day and first week after cataract surgery (p=0.026) in all the three groups. However, the mean IOP in three different groups was not statistically significant at 1st week, 3rd week and at 6th week after cataract surgery (Table/Fig 4).

The results of a mixed model repeated measures ANOVA using type of drug as between subjects’ factor and time as within subjects’ factor, and IOP as dependent variable showed that the IOP was significantly affected by time, F (2.4, 353)=5.65, p=0.002. However, Eta2 effect size (?2=0.037) indicated that only 3.7% of the variance was accounted for by time (Table/Fig 5). As evident in (Table/Fig 6), on the first day after cataract surgery, 7 patients had IOP >31 mmHg. At the end of first week after cataract surgery, two patients developed IOP >31 mmHg. Both patients belonged to difluprednate group, whereas eight patients had IOP between 21-30 mmHg. Out of these, five patients belonged to dexamethasone group, two patients belonged to prednisolone group and one patient to difluprednate group. At the end of 3rd week, only one patient belonging to difluprednate group had IOP >31 mmHg. Four patients had IOP between 21-30 mmHg. Out of these, one patient belonged to dexamethasone group, two patients belonged to prednisolone group and one patient to difluprednate group.

At the end of 6th week, no patient had IOP >31 mmHg. Twelve patients had IOP between 21-30 mmHg. Six patients belonged to dexamethasone group, two patients belonged to prednisolone group and four patients belonged to difluprednate group (Table/Fig 6). There were no cases of severe uveitis in postoperative six-week period requiring more frequent use of topical steroids or oral and injectable steroids.

Discussion

The mean preoperative IOP in the present study was 15.93±2.63 mmHg, with mean preoperative IOP in dexamethasone group being 15.71±2.65 mmHg, 15.96±2.71 mmHg in prednisolone group and 16.11±2.56 mmHg in difluprednate group. This correlates with the studies of Kaur R et al., with mean preoperative IOP in prednisolone group being 15.66±1.91 mmHg (11). Reddy R and Patil A noted mean preoperative IOP of 15.66±1.96 mmHg in Difluprednate group and 15.57±1.96 mmHg in dexamethasone group (12). Bartin M et al., noted mean IOP of 14.93±2.23 mmHg in difluprednate group and 15.38±2.23 mmHg in prednisolone group (13).

The mean postoperative IOP at first day after cataract surgery was 17.35±5.87 mmHg, with mean IOP of 17.49±5.29 mmHg in the dexamethasone group, 17.31±6.69 mmHg in the prednisolone group and 17.24±5.65 mmHg in the difluprednate group (p-value=0.977, f-value=0.023). Similar findings were noted by Kaur R et al., with mean IOP of 17.93±2.31 mmHg in the prednisolone group and Saari KM et al., with mean IOP of 16.8±6.7 mmHg in the dexamethasone phosphate group (11),(14). Rehman M et al., noted mean IOP of 15.93±0.58 mmHg in the dexamethasone group on the first postoperative day (15). In a study by Kamal DS et al., 12% patients developed an IOP >25 mmHg on the first day after cataract surgery corroborating well with the present study (16). There was statistically significant difference in mean preoperative IOP and mean IOP on the first day after cataract surgery with p-value of 0.035. This postoperative rise in IOP on the first day after the cataract surgery is mainly due to the postoperative inflammation and retained visco-elastic material.

The mean IOP at the end of first week was 15.76±4.23 mmHg, with mean IOP of 15.74±3.61 mmHg in dexamethasone group, 14.96±3.38 mmHg in the prednisolone group and 16.58±5.36 mmHg in difluprednate group (p-value=0.158, f-value=1.866). El Saman IS et al., noted mean IOP of 15.8±4.5 mmHg in prednisolone group and 16.5±5.5 mmHg in the difluprednate group at the end of first week, with no significant difference in the mean IOP between the groups (17). Kusne Y et al., noted a mean IOP of 15.6±4.3 mmHg in the prednisolone group and 16.2±4.2 mmHg in the difluprednate group (18). Rehman M et al., noted mean IOP of 15.89±0.82 mmHg with dexamethasone (15). Saari KM et al., recorded mean IOP of 16.5±8.1 mmHg in the dexamethasone phosphate group (14). There was statistically significant difference between mean IOP at the end of 1st week after cataract surgery and mean IOP at the first day after cataract surgery (p-value=0.026), with mean IOP being high at the first day after cataract surgery. This decrease in mean IOP in all the three drug groups at the end of first week is due to resolution of inflammation by the topical steroids.

The mean IOP at the end of 3rd week was 15.95±3.26 mmHg, with mean IOP of 15.79±2.77 mmHg in the dexamethasone group, 15.43±2.66 mmHg in the Prednisolone group and 16.64±4.11 mmHg in the Difluprednate group (p-value=0.163, f-value=1.837). El Saman IS et al., noted mean IOP of 14.9±4.8 mmHg in the prednisolone group and 15.1±5.0 mmHg in the difluprednate group and Tijunelis MA et al., noted a mean IOP of 14.3±3.4 mmHg in the prednisolone group and 14.5±3.6 mmHg in the difluprednate group (17),(19). Reddy R and Patil A noted IOP of 16.98±1.58 mmHg in the difluprednate group at the end of 1 month similar to this study but mean IOP in dexamethasone group was 17.06±1.53 mmHg, which was different from this study (12).

The mean IOP at the end of 6th week was 16.19±3.14 mmHg, with mean IOP of 16.03±3.12 mmHg in dexamethasone group, 15.59±3.19 mmHg in prednisolone group and 16.96±3.00 mmHg in the difluprednate group (p-value=0.08, f-value=2.53). El Saman IS et al., noted a mean IOP of 14.6±3.9 mmHg in the dexamethasone group and 14.9±4.4 mmHg in the difluprednate group and Bartin M et al., noted mean IOP of 15.71±2.2 mmHg in the difluprednate group and 15.95±2.13 mmHg in the prednisolone group, Whereas, Gupta V and Gupta D noted mean IOP of 18.62±2.36 mmHg in prednisolone group at 6th week and Kaur R et al., noted mean IOP of 25.66±2. Twelve mmHg in prednisolone group at the end of one month (11),(13),(17),(20).

During the six week course of topical corticosteroid therapy, Smith S et al., noted an IOP rise of >21 mmHg in three patients (3.7%) on difluprednate therapy (21). Sahasrabudhe VM and Kamble NR noted an IOP >21 mmHg in two patients (3.57%) on difluprednate therapy (22). Sowbhagya HN et al., recorded IOP >21 mmHg in five patients, out of which three patients had risen of IOP after 1st week (23). El Saman IS et al., noted IOP >21 mmHg in five patients (2.9%) on difluprednate, out of which two had IOP >31 mmHg (17). Sood P and Sood P had three patients (3.7%) in difluprednate group, who developed IOP >21 mmHg (24). All these findings, are in tune with the present study, in which three patients developed IOP >31 mmHg. Reddy R and Patil A had no patients showing IOP >21 mmHg over a period of one month in both dexamethasone and difluprednate groups (12).

Limitation(s)

Follow-up period was short in order to evaluate the long-term effects of steroids on IOP as drug effects were observed for six weeks only and grading of inflammation as measured by cells and flare was not done.

Conclusion

In the present study, all three steroids were equally safe and did not cause any statistically significant rise in IOP over six-week postoperative period. Hence, any of the three drugs can be safely used to manage postoperative inflammation in patients undergoing cataract surgery. However, caution is advised with use of Difluprednate 0.05%, as higher IOP (clinically significant) values were noted in two patients with it at the end of 1st week and in one patient at the end of 3rd week after cataract surgery.

Acknowledgement

Our sincere thanks to all the participants of the trial for their support in regular follow-up and compliance.

References

1.
Sherif M, El-Harazi SM, Feldman RM. Control of intra-ocular inflammation associated with cataract surgery. Curr Opin Ophthalmol. 2001;12(1):04-08. [crossref] [PubMed]
2.
Schalnus R. Topical non-steroidal anti-inflammatory therapy in ophthalmology. Ophthalmologica. 2003;217(2):89-98. [crossref] [PubMed]
3.
Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009;35(1):26-34. [crossref] [PubMed]
4.
Pleyer U, Ursell PG, Rama P. Intraocular pressure effects of common topical steroids for postcataract inflammation: Are they all the same? Ophthalmol Ther. 2013;2(2):55-72. [crossref] [PubMed]
5.
Doughty MJ. Ophthalmic corticosteroids: Management of the ocular inflammatory response. In: Ocular pharmacology & therapeutics. 5th edn. London: Butterworth-Heinemann; 2001. Pp. 92-102. [crossref]
6.
Bartlett JD, Horwitz B, Laibovitz R, Howes JF. Intraocular pressure response to loteprednol etabonate in known steroid responders. J Ocul Pharmacol. 1993;9(2):157-65. [crossref] [PubMed]
7.
Clark AF, Wilson K, de Kater AW, Allingham RR, McCartney MD. Dexamethasone-induced ocular hypertension in perfusion-cultured human eyes. Invest Ophthalmol Vis Sci. 1995;36(2):478-89.
8.
Allingham RR, Damji KF, Freedman S, Moroji SE, Rhee DJ. Steroid induced Glaucoma, In. Shields Texbook of Glaucoma. 6th edition. Wolters Kluwer Publishers, New Delhi; 2011. Pp: 344-47.
9.
Sendrowski DP, Jannus SD, Semes LP, Stern ME. Anti-Inflammatory Drugs. In: Barett JD, Jannus SD, editor. Clinical Ocular Pharmacology, 5th ed. St. Louis Missouri, USA: Butterworth-Heinemann Publishers; 2008.Pp. 221-33. [crossref]
10.
Chylack LT Jr, Wolfe JK, Singer DM, Leske MC, Bullimore MA, Bailey IL, et al. The Lens Opacities Classification System III. The Longitudinal Study of Cataract Study Group. Arch Ophthalmol. 1993;111(6):831-36. [crossref] [PubMed]
11.
Kaur R, Matreja, Khan B, Bhatnagar R. Compare the safety and efficacy of loteprednol etabonate 0.5% and prednisolone acetate 1% in the postoperative inflammation following cataract extraction with intra ocular lens implant. AABS. 2015;2(4):106-10.
12.
Reddy R, Patil A. Comparative study of efficacy of topical dexamethasone 0.1% with difluprednate 0.05% in postoperative small incision cataract surgery. Ind J Clin Exp Ophthalmol. 2018;4(3):339-46. [crossref]
13.
Bratin M, Puzari BS. Efficacy and safety of difluprednate ophthalmic emulsion and prednisolone acetate ophthalmic suspension in postcataract surgery inflammation- a comparative study. IOSR Journal of Dental and Medical Sciences. 2016;15(3):51-58. [link available:https://www.iosrjournals.org/iosr-jdms/papers/Vol15-Issue%203/Version-7/M1503075158.pdf].
14.
Saari KM, Nelimarkka L, Ahola V, Loftsson T, Stefansson. Comparison of topical 0.7% dexamethasone-cyclodextrin with 0.1% dexamethasone sodium phosphate for postcataract inflammation. Graefe's Arch Clin Exp Ophthalmol. 2006;244(5):620-26. [crossref] [PubMed]
15.
Rehman M, Ahmed I, Bashir B, Tahir MZ, Shah AA. Effects of topical dexamethasone on intra-ocular pressure when used after phacoemulsification with Intra-ocular lens implantation. Isra Medical Journal. 2015;7(3):142-45.
16.
Kamal DS, Aggarwal SV, Bareth K, Shah N. Study of steroid induced rise in intraocular pressure using non-contact tonometer after cataract surgery in camp patients at PDU Medical College Rajkot, Gujarat. Natl J Med Res. 2012;2(2):169-72.
17.
El Saman IS, Mostafa EM, Kamel AG, Mohammad OA. Comparison of difluprednate 0.05% versus prednisolone acetate 1% eye drops following uneventful cataract surgery. J Clin Ophthalmol 2018;2(2):101-04. [link available:https://www.alliedacademies.org/articles/comparison-of-difluprednate-005-versus-prednisolone-acetate-1-eyedrops-following-uneventful-cataract-surgery.pdf].
18.
Kusne Y, Kang P, Fintelmann RE. A retrospective analysis of intraocular pressure changes after cataract surgery with the use of prednisolone acetate 1% versus difluprednate 0.05%. Clin Ophthalmol. 2016;10:2329-36. [crossref] [PubMed]
19.
Tijunelis MA, Person E, Niziol LM, Musch DC, Ernest P, McBain M, et al. Comparison of prednisolone acetate 1% and difluprednate ophthalmic emulsion 0.05% after cataract surgery: Incidence of postoperative steroid-induced ocular hypertension. J Cataract Refract Surg. 2017;43(2):223-27. [crossref] [PubMed]
20.
Gupta V, Gupta D. To compare the safety & efficacy of loteprednol etabonate 0.5% & prednisolone acetate 1% in the post-operrative inflammation following cataract extraction with intraocular lens implantation. JK Science. 2018;20(2):73-76.
21.
Smith S, Lorenz D, Peace J, McLeod K, Crockett RS, Vogel R. Difluprednate ophthalmic emulsion 0.05% (Durezol) administered two times daily for managing ocular inflammation and pain following cataract surgery. Clin Ophthalmol. 2010;4:983-91. [crossref] [PubMed]
22.
Sahasrabudhe VM, Kamble NR. Study of effect of topical 0.05% difluprednate on intra ocular pressure in patients operated by small incision cataract surgery. Saudi J Med Pharm Sci. 2016;3(2):56-58.
23.
Sowbhagya HN, Manjunath N, Shetty S, Kumar LK. Intraocular pressure changes with the use of difluprednate: An observational study. Int J Sci Stud. 2015;3(5):54-57. [link available: http://www.ijss-sn.com/uploads/2/0/1/5/20153321/ijss_aug_oa11.pdf].
24.
Sood P, Bhanot M. Comparison of efficacy of difluprednate 0.05% vs dexamethasone 0.1% eye drops in inflammation associated with small incision cataract surgery. Int J Basic Clin Pharmacol. 2017;6:1526-29. [crossref]

DOI and Others

10.7860/JCDR/2021/47085.15071

Date of Submission: Oct 06, 2020
Date of Peer Review: Dec 23, 2020
Date of Acceptance: May 05, 2021
Date of Publishing: Jul 01, 2021

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Oct 06, 2020
• Manual Googling: May 04, 2021
• iThenticate Software: May 28, 2021 (17%)

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