Uveitis, Anterior
Conditions
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
Interventions
DRUGDifluprednate Eye Drops
post-operative cataract surgery medication regimen. but different dosages between the 2 groups.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior chamber examination for flare and cell | 3 months | using SUN classification |
Countries
Egypt
Contacts
Primary ContactAhmed Hashem, PhD
Outcome results
None listed