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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Intraocular Pressure

Treatments: Drug: 0.1 % Dexamethasone; Drug: 0.1% Fluorometholone; Drug: 1% Rimexolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02816905

Abeer Al Hanaineh

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 40 patients

Sex: All

Ages: Under 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 3 patient groups

Group A

Active Comparator group

Description:

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.

Treatment:

Drug: 0.1 % Dexamethasone

Group B

Active Comparator group

Description:

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.

Treatment:

Drug: 0.1% Fluorometholone

Group C

Active Comparator group

Description:

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.

Treatment:

Drug: 1% Rimexolone