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

NCT ID: NCT02816905

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-06-30

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®.

Conditions

Intraocular Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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 Type: ACTIVE_COMPARATOR

0.1 % Dexamethasone

Intervention Type: DRUG

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

Group B

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 Type: ACTIVE_COMPARATOR

0.1% Fluorometholone

Intervention Type: DRUG

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

Group C

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.

Group Type: ACTIVE_COMPARATOR

1% Rimexolone

Intervention Type: DRUG

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

Interventions

0.1 % Dexamethasone

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

Intervention Type: DRUG

0.1% Fluorometholone

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Topical steroid; Topical steroid; Topical steroid

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.

• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abeer Tawfik Al Hanaineh

Doctor Abeer Tawfik Farhan Al Hanaineh

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar M. El Shafie El Zawahry, PhD

Role: STUDY_CHAIR

Cairo University Hospital- Department of Ophthalmology

Locations

Cairo University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Abeer Al Hanaineh

Identifier Type: -

Identifier Source: org_study_id