Original Research Article DOI: 10.18231/2395-1451.2018.0076 Comparative study of efficacy of topical dexamethasone 0.1% with difluprednate 0.05% in post-operative small incision cataract surgery Rajashree Reddy1, Ashwini Patil2,* 1Associate Professor, 2Post Graduate Student, Dept. of Ophthalmology, Mahadevappa Rampure Medical College, Kalaburagi, Karnataka, India *Corresponding Author: Email: [email protected] Abstract Introduction: Post-operative ocular inflammation is a common occurrence following cataract surgery. Corticosteroids have been used to treat ocular inflammation; however, they carry a risk of side effects, particularly an increase in intra ocular pressure (IOP). Previous studies have proved that difluprednate is more efficacious compared to dexamethasone. Hence this study was undertaken to compare the efficacy of difluprednate ophthalmic emulsion 0.05% and dexamethasone 0.1% in postoperative management after small incision cataract surgery. Materials and Methods: A total 200 patients were selected as per inclusion criteria and equally divided between difluprednate and dexamethasone groups. Dexamethasone 0.1% or difluprednate0.05% was prescribed post operatively following small incision cataract surgery. Patients were examined on post-operative day 1, 7, 15 and 30 for anterior segment by slit-lamp examination and side effects. IOP was measured in both the groups on day 30. Results: In our observation both drugs were efficient in the reduction of anterior chamber cells and flare with difluprednate being more rapid. Corneal edema was reduced equally by both the drugs at all observation periods. There was no clinically significant IOP elevation in both difluprednate and dexamethsone group. Difluprednate was found to be more effective in controlling pain compared to dexamethasone. Conclusion: As per present study both difluprednate ophthalmic emulsion 0.05% eye drops and dexamethasone 0.1% eye drops were equally effective in reducing post cataract surgery inflammation. Hence, difluprednate emulsion 0.05% can be used in post- operative management after cataract surgery; nonetheless, further clinical trials with long follow- up period are required. Keywords: Cataract surgery, Dexamethasone, Difluprednate, Dose uniformity, Ocular inflammation, Opthalmic emulsion. Introduction inflammation and high chance of maintenance of The major cause of the blindness across the globe is integrity of blood aqueous barrier. In 1950, with the cataract, and around 1 to 4% population of the world arrival of cortisone in the medical field, there was major suffers from blindess. Cataract surgery should be advancement in the management of inflammatory performed with equal emphasis on quality and quantity conditions.3 of surgery.1 Surgical techniques in all fields of In the immediate post-operative period, topical ophthalmology has evolved considerably over the years corticosteroids are employed to suppress the production from transition to clear corneal incisions by anterior of inflammatory mediators, providing local treatment segment surgeons to adoption of small-gauge minimally without any side effects. Corticisteriods prevent the invasive pars planavitrectomies by vitreo- retinal release of arachidonic acid from cell membrane specialists. Cataract surgery can cause ocular phospholipids there by inhibiting the genesis of inflammation and it could be due to surgical trauma itself prostaglandins and leukotrines contributing to the and due to various physical, chemical and biological disruption of the inflammatory cascade. These agents are agents introduced during the surgery. The host response continued until the anterior chamber (AC) reaction has to these injurious agents in the form of inflammation is a resolved and the blood- aqueous barrier has been re- complex interaction of immuno reactive cells, their established.4 Routinely topical corticosteroids are in use products and other chemical mediators of inflammation. for the reduction of inflammation after surgery but side More is known today about chemical mediators of effects of corticosteriods are; inhibition of wound inflammation; the prostaglandins, the kinins the healing, high risk of infections and in some patients complement system etc and their role in inflammation. It intraocular hypertension also seen.5 is becoming more apparent that prostaglandins help to 0.05% difluprednate got US food and drug mediate the response of eye to acute trauma. This administration (FDA) approval in June 2008 for post- response is marked by miosis, hyperemia of conjunctiva, operative management of inflammation and pain. This is disturbance of blood aqueous barrier and transient the first ophthalmic steroid approved by FDA since increase in intraocular pressure followed by 1973. A study conducted showed that difluprednate hypotension.2 In the last few years cataract surgery emulsion 0.05% safely decreased the inflammation operative techniques have been improved tremendously associated with cataract surgery with no serious adverse and it has become least traumatic. And due to this effects compared to placebo. Thus difluprednate in the improved cataract surgeries there is low chance of ocular Indian Journal of Clinical and Experimental Ophthalmology, July-September, 2018;4(3):339-346 339 Rajashree Reddy et al. Comparative study of efficacy of topical dexamethasone… past 35 years has proved to be high potent, safe, and Patients in Group B received dexamethasone eye drops effectively reduces the post-operative pain.6 8 times and Moxifloxacin eye drops 4 times in a day for The emulsion formulations of difluprednate can be the 1st week followed by tapering of dexamethasone till credited to its dose uniformity.7 6th week. Various studies have proved that difluprednate is On 1,7,15 and 30 days of post-operative period each more efficacious compared to dexamethasone. There are patient was examined for pain, watering or any other few studies about the comparison of efficacy of symptom which has been experienced by the patient. For difluprednate and dexamethasone. Hence this study was the assessment of inflammation slit lamp examination undertaken to compare the efficacy of difluprednate was carried out and Snellen’s chart was used to assess ophthalmic emulsion 0.05% and dexamethasone 0.1% in visual acuity. With maintenance of standard conditions postoperative management after small incision cataract slit lamp examination was carried out: room was surgery. illuminated with dim light, voltage of the lamp was high, 3x1 millimeter aperture for Anterior chamber Flare and Materials and Methods Cells (Hogan’s grading). 30 degrees was used as Total two hundred patients diagnosed with senile illumination angle and magnification of 16x. Visual cataracts reported to HKE Society’s Basaveshwara analogue scale (VAS) was used to determine ocular pain. General and Teaching Hospital, Kalaburagi have been Symptoms of watering and discomfort were recorded as selected for the research. The study period was from present or absent. December 2015 to June 2017. Before the start of the At each visit the following parameters were noted study informed consent of the patient was acquired and and the degree of parameters are graded as 0,1,2,3, etc permission from the institutional ethical committee was As per VAS scale pain is graded as 0-absent, 1- procured. mild, 2-moderate, 3-severe and 4-extreme. A total of two hundred patients with senile cataract Corneal edema grading; 0- none, 1- mild, 2 - were divided into two groups. moderate, 3 -severe Group A- 100 cases (Difluprednate ophthalmic emulsion Anterior chamber flare grading: 0- absent, 1- mild, 0.05% group) 2- moderate (iris and lense details seen), 3- severe (iris Group B- 100 cases (Dexamethasone phosphate and lense details seen). ophthalmic suspension 0.1% group) Anterior chamber cells grading: grade 0 -absent, Inclusion Criteria: Patients diagnosed with cataract grade 1- 5 to 10 cells, grade 2 -11 to 20 cells, grade 3- 20 aged more than 40yrs and undergoing small incision to 50 cells. cataract surgery with PC IOL implantation. (If 50 cells and hypopyon was graded as 4 than Exclusion Criteria: Below years old patients, patients Pupils were examined for any synechiae or any other on long term steroids or NSAIDS, Patients sensitive to abnormalities). The details of the fundus were also noted any of the study or procedural medicines, patients with especially in the macula for the presence of cystoid preoperative inflammation in either eye, patients with macular edema by direct ophthalmoscopy. H/O ocular trauma, previous intraocular surgery or wear After 1 month, intraocular pressure was measured of contact lens, patients developing intraoperative with the help of applanation Tonometer and best complications, patients not giving consent, and patients corrected visual acuity was got after doing refraction. All undergoing phacoemulsification the above details were recorded in the clinical proforma Methodology: Before surgical procedure the patients at each visit. were evaluated for following; history was evaluated, slit Statistical analysis was done using Chi-square test lamp examination of the patient was done, visual acuity with Yate’s correction and Wilcoxon Signed Ranks test. was assessed, Keratometry has been done, A-scan has Statistical analysis using descriptive statistics and been done, and routine pre-operative blood inferential statistics has been done for this study. The investigations was carried out and blood pressure was results were analysed by using SPSS version