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

Phase 4

Completed

• Conditions: Intraocular Pressure
• Interventions: Drug: 0.1 % Dexamethasone; Drug: 0.1% Fluorometholone; Drug: 1% Rimexolone

• Registration Number: NCT02816905
• Lead Sponsor: Cairo University

Brief 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®.

Study Timeline

• Study Start: 2015-10
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-06-26
• Study First Submitted QC: 2016-06-26
• Last Update Submitted: 2016-06-26
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children younger than 13 years of age.
• Children who underwent bilateral recession strabismus surgeries.
• Preoperative IOP of 21.00 mmHg or less, with a cup-disc ratio of 0.3 or less.
• The absence of systemic disease and ocular disease (apart from strabismus) in both eyes.
• Children who can comply with the IOP measurements using the Tono-Pen®, as no type of anesthesia will be used, except for the topical anesthesia.

Exclusion Criteria

• Patients that are 13 years of age or older.
• Children who need resection muscle surgeries, surgeries for the vertical, or the oblique muscles.
• Preoperative IOP of more than 21.00 mmHg, or a cup-disc ratio of more than 0.3
• Family history of glaucoma or high myopia.
• A history of steroid usage in the past year.
• Failure to comply with IOP measurements or the follow-up schedule.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	0.1 % Dexamethasone	20 eyes that received topical 0.1% Dexamethasone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery.
Group B	0.1% Fluorometholone	20 eyes that received topical 0.1 % Fluorometholone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery.
Group C	1% Rimexolone	40 eyes that received topical 1% Rimexolone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery.

Primary Outcome Measures

Name	Time	Method
Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroids are used in children under 12 years of age, who underwent bilateral strabismus surgery	IOP will be followed up for 6 weeks after initial use	Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroid use in children. IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6. And will be compared with pre-operative values.

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt