NCT02816905

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Detailed 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®.

Conditions

• Intraocular Pressure

Interventions

Type	Name	Description
DRUG	0.1 % Dexamethasone	20 eyes are randomized to receive topical 0.1% Dexamethasone four times per day for 2 weeks.
DRUG	0.1% Fluorometholone	20 eyes are randomized to receive topical 0.1% Fluorometholone four times per day for 2 weeks.
DRUG	1% Rimexolone	40 eyes are randomized to receive topical 1% Rimexolone four times per day for 2 weeks. 20 of these eyes were the contralateral eyes of the patients who received 0.1% Dexamethasone in their first eye. The other 20 eyes were the contralateral eyes of the patients who received 0.1% Fluorometholone in their first eye

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-06-29
• Last updated: 2016-06-29

Locations

1 site across 1 country: Egypt