Clinical trial NCT02816905: Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery
Official title: Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery (Topical Rimexolone Versus Topical Dexamethasone and Topical Fluorometholone)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraocular Pressure
Keywords: intraocular pressure
topical steroids
strabismus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 40
Sex: ALL
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: IOP will be followed up for 6 weeks after initial use
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University Hospital- Department of Ophthalmology
name: Omar M. El Shafie El Zawahry, PhD
role: STUDY_CHAIR
References: