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

Primary Purpose

Uveitis, Anterior

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Difluprednate Eye Drops
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis, Anterior

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kafrelsheikh UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Anterior chamber examination for flare and cell
using SUN classification

Secondary Outcome Measures

Full Information

First Posted
November 25, 2022
Last Updated
December 12, 2022
Sponsor
Kafrelsheikh University
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1. Study Identification

Unique Protocol Identification Number
NCT05649111
Brief Title
A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification
Official Title
A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Anterior

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Difluprednate Eye Drops
Intervention Description
post-operative cataract surgery medication regimen. but different dosages between the 2 groups.
Primary Outcome Measure Information:
Title
Anterior chamber examination for flare and cell
Description
using SUN classification
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Hashem, PhD
Phone
+201003828881
Email
ahmed_hashiem@med.kfs.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Hashem, PhD
Organizational Affiliation
Kafrelsheikh university faculty of medicin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafrelsheikh University
City
Kafr Ash Shaykh
ZIP/Postal Code
33516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Hashem
Phone
+201003828881
Email
ahmed_hashiem@med.kfs.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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