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

Sponsor

Kafrelsheikh University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05649111

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis, Anterior	Drug: Difluprednate Eye Drops	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 operationGroup 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:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Anterior chamber examination for flare and cell [3 months]
using SUN classification

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kafrelsheikh University	Kafr Ash Shaykh		Egypt	33516

Sponsors and Collaborators

Kafrelsheikh University

Investigators

Principal Investigator: Ahmed Hashem, PhD, Kafrelsheikh university faculty of medicin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Hashiem, Lecturer of ophthalmology ,ophthalmology consultant, Kafrelsheikh University

ClinicalTrials.gov Identifier:

NCT05649111

Other Study ID Numbers:

50-11-16

First Posted:

Dec 13, 2022

Last Update Posted:

Dec 13, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2022