Back to resultsOcular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery
Primary Purpose
Intraocular Pressure
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
0.1 % Dexamethasone
0.1% Fluorometholone
1% Rimexolone
Sponsored by
About this trial
This is an interventional treatment trial for Intraocular Pressure focused on measuring intraocular pressure, topical steroids, strabismus
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.
Sites / Locations
- Cairo University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm 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.
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.
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.
Outcomes
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02816905
Brief Title
Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery
Official Title
Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery (Topical Rimexolone Versus Topical Dexamethasone and Topical Fluorometholone)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
5. 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.
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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure
Keywords
intraocular pressure, topical steroids, strabismus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm 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.
Arm Title
Group B
Arm Type
Active Comparator
Arm 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.
Arm Title
Group C
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
0.1 % Dexamethasone
Other Intervention Name(s)
Topical steroid
Intervention Description
20 eyes are randomized to receive topical 0.1% Dexamethasone four times per day for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
0.1% Fluorometholone
Other Intervention Name(s)
Topical steroid
Intervention Description
20 eyes are randomized to receive topical 0.1% Fluorometholone four times per day for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
1% Rimexolone
Other Intervention Name(s)
Topical steroid
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
IOP will be followed up for 6 weeks after initial use
10. Eligibility
Sex
All
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar M. El Shafie El Zawahry, PhD
Organizational Affiliation
Cairo University Hospital- Department of Ophthalmology
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery
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