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

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.

Study Overview

• Status: Recruiting
• Conditions: Uveitis, Anterior
• Intervention / Treatment: Drug: Difluprednate Eye Drops

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed Hashem, PhD; Phone Number: +201003828881; Email: ahmed_hashiem@med.kfs.edu.eg

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt, 33516
    • Recruiting
    • Kafrelsheikh University
    • Contact: Ahmed Hashem; Phone Number: +201003828881; Email: ahmed_hashiem@med.kfs.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Difluprednate Eye Drops; post-operative cataract surgery medication regimen. but different dosages between the 2 groups.
Active Comparator: 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	Drug: Difluprednate Eye Drops; post-operative cataract surgery medication regimen. but different dosages between the 2 groups.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: Ahmed Hashem, PhD, Kafrelsheikh university faculty of medicin

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Panuveitis; Uveal Diseases; Uveitis; Uveitis, Anterior; Physiological Effects of Drugs; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmaceutical Solutions; Ophthalmic Solutions; Difluprednate
• Other Study ID Numbers: 50-11-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No