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

• ClinicalTrials.gov Identifier: NCT02816905
• Recruitment Status: Completed
• First Posted: June 29, 2016
• Last Update Posted: June 29, 2016
• Sponsor: Cairo University
• Information provided by (Responsible Party): Abeer Tawfik Al Hanaineh, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intraocular Pressure	Drug: 0.1 % Dexamethasone; Drug: 0.1% Fluorometholone; Drug: 1% Rimexolone	Phase 4

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®.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery (Topical Rimexolone Versus Topical Dexamethasone and Topical Fluorometholone)
• Study Start Date: October 2015
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Drug: 0.1 % Dexamethasone; 20 eyes are randomized to receive topical 0.1% Dexamethasone four times per day for 2 weeks.; Other Name: Topical steroid
Active Comparator: 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.	Drug: 0.1% Fluorometholone; 20 eyes are randomized to receive topical 0.1% Fluorometholone four times per day for 2 weeks.; Other Name: Topical steroid
Active Comparator: 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.	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; Other Name: Topical steroid

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: IOP will be followed up for 6 weeks after initial use ]
   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.

Eligibility Criteria

• Ages Eligible for Study: up to 13 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Egypt

Cairo University Hospitals

Cairo, Egypt

Sponsors and Collaborators

Cairo University

Investigators

• Study Chair: Omar M. El Shafie El Zawahry, PhD; Cairo University Hospital- Department of Ophthalmology

More Information

• Responsible Party: Abeer Tawfik Al Hanaineh, Doctor Abeer Tawfik Farhan Al Hanaineh, Cairo University
• ClinicalTrials.gov Identifier: NCT02816905
• Other Study ID Numbers: Abeer Al Hanaineh
• First Posted: June 29, 2016
• Last Update Posted: June 29, 2016
• Last Verified: June 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Abeer Tawfik Al Hanaineh, Cairo University:

intraocular pressure; topical steroids; strabismus

Additional relevant MeSH terms:

Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Fluorometholone; Dexamethasone; Rimexolone; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anti-Allergic Agents