Overview

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

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cairo University
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Fluorometholone
Rimexolone
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-PenĀ®, 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.