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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816905
• Other study ID #: Abeer Al Hanaineh
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2016
• Last updated: June 26, 2016
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

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.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 13 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Intraocular Pressure
• Strabismus

Intervention

Drug:
• 0.1 % Dexamethasone
20 eyes are randomized to receive topical 0.1% Dexamethasone four times per day for 2 weeks.
• 0.1% Fluorometholone
20 eyes are randomized to receive topical 0.1% Fluorometholone four times per day for 2 weeks.
• 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

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	IOP will be followed up for 6 weeks after initial use	No