A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification
- Registration Number
- NCT05649111
- Lead Sponsor
- Kafrelsheikh University
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Difluprednate Eye Drops 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 Group A Difluprednate Eye Drops 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
- Primary Outcome Measures
Name Time Method Anterior chamber examination for flare and cell 3 months using SUN classification
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kafrelsheikh University
🇪🇬Kafr Ash Shaykh, Egypt