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

Uveitis, Anterior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649111
• Other study ID #: 50-11-16
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: December 2022
• Source: Kafrelsheikh University
• Contact: Ahmed Hashem, PhD
• Phone: +201003828881
• Email: ahmed_hashiem[@]med.kfs.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Uveitis
• Uveitis, Anterior

Intervention

Drug:
• Difluprednate Eye Drops
post-operative cataract surgery medication regimen. but different dosages between the 2 groups.

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior chamber examination for flare and cell	using SUN classification	3 months