A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification

Study Overview
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Brief Summary
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The study aims at detecting the minimum effective daily dose and duration of difluprednate that can be used to treat postoperative inflammation after phacoemulsification without increasing the intraocular pressure, and whether it can be safely given within the first 24 hours after the operation.

Detailed Description
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Conventional phacoemulsification will be performed by the same surgeon for all the cases using the stop and chop technique. Anterior chamber examination for flare and cells using slit-lamp biomicroscopy according to the SUN recommendations and intraocular pressure measurement using Goldmann applanation tonometer will be done for all the cases before surgery and on the 1st, 3rd, 7th, 14th days as well as one month after the procedure. All cases will receive Nepafenac 0.1% ( Nevanac 0.1%) 3 times per day on the last preoperative day, one tablet of Acetazolamide 250 mg (Cidamex 250mg) within the first 3 hours after the procedure and Moxifloxacin (Vigamox 0.5%) 0.1 ml intracameral and post-operative drops 3 times per day for 10 days and will be divided into: In this pilot study: Group A : will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation Group B : will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation

Official Title
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A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification

Conditions
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Uveitis, Anterior

Intervention / Treatment
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* Drug: Difluprednate Eye Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-80 Grade 1 to 4 nuclear cataract LOCS II Cumulative dissipated energy CDE 1 to 10 Done by a single surgeon using the chopping technique Exclusion Criteria: History of uveitis the use of topical or systemic steroids on the last post-operative day Intraoperative or postoperative complications Intraoperative iris manipulations or phaco traume

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A (FDA dose): will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation Group B will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation | Drug: Difluprednate Eye Drops<br>* post-operative cataract surgery medication regimen. but different dosages between the 2 groups.<br>|
| Active Comparator: Group B<br>will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation | Drug: Difluprednate Eye Drops<br>* post-operative cataract surgery medication regimen. but different dosages between the 2 groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior chamber examination for flare and cell | using SUN classification | 3 months |