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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT02816905

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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

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 :

Oct 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 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 Names: 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 Names: 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 Names: Topical steroid

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 Names:

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 Names:

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 Names:

Topical steroid

Outcome Measures

Primary Outcome Measures

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 [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

Criteria

Ages Eligible for Study:

N/A to 13 Years

Sexes Eligible for Study:

All

Accepts 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.