Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery

Intraocular Pressure Clinical Trial

Official title: Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery (Topical Rimexolone Versus Topical Dexamethasone and Topical Fluorometholone)

Status Completed

Clinical Trial Summary

This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the children under 13 years of age who underwent bilateral strabismus surgery.

Clinical Trial Description

Children under the age of 13 years undergoing bilateral strabismus surgery in Cairo University Hospitals (Cairo University Specialized Pediatric Hospital and Kasr Al Ainy Hospital). will be randomized using simple randomization method, computer software for randomization, into two equal groups:

• First group: One eye is randomized to receive topical 0.1% Dexamethasone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.

• Second group: One eye is randomized to receive topical 0.1% Fluorometholone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.

IOP will be measured on the day before operation using the Tono-Pen®. Three reliable measurements will be obtained from each eye and the mean will be taken.

IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6 using the Tono-Pen®. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Pressure
• Strabismus

• NCT number: NCT02816905
• Study type: Interventional
• Source: Cairo University
• Status: Completed
• Phase: Phase 4
• Start date: October 2015
• Completion date: June 2016