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

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

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®.

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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

Resource links provided by the National Library of Medicine


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816905


Locations
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Egypt
Cairo University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Omar M. El Shafie El Zawahry, PhD Cairo University Hospital- Department of Ophthalmology
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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    Key Record Dates
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:
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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