Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-21 @ 6:50 PM
Study NCT ID:
NCT02816905
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2016-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D005469', 'term': 'Fluorometholone'}, {'id': 'C013769', 'term': 'rimexolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D011244', 'term': 'Pregnadienediols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-26', 'studyFirstSubmitDate': '2016-06-26', 'studyFirstSubmitQcDate': '2016-06-26', 'lastUpdatePostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'IOP will be followed up for 6 weeks after initial use', '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.'}]}, 'conditionsModule': {'keywords': ['intraocular pressure', 'topical steroids', 'strabismus'], 'conditions': ['Intraocular Pressure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n* 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.\n* 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.\n\nIOP 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.\n\nIOP will be measured at postoperative weeks 1, 2, 3, 4 and 6 using the Tono-Pen®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children younger than 13 years of age.\n* Children who underwent bilateral recession strabismus surgeries.\n* Preoperative IOP of 21.00 mmHg or less, with a cup-disc ratio of 0.3 or less.\n* The absence of systemic disease and ocular disease (apart from strabismus) in both eyes.\n* 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.\n\nExclusion Criteria:\n\n* Patients that are 13 years of age or older.\n* Children who need resection muscle surgeries, surgeries for the vertical, or the oblique muscles.\n* Preoperative IOP of more than 21.00 mmHg, or a cup-disc ratio of more than 0.3\n* Family history of glaucoma or high myopia.\n* A history of steroid usage in the past year.\n* Failure to comply with IOP measurements or the follow-up schedule.'}, 'identificationModule': {'nctId': 'NCT02816905', 'briefTitle': 'Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery (Topical Rimexolone Versus Topical Dexamethasone and Topical Fluorometholone)', 'orgStudyIdInfo': {'id': 'Abeer Al Hanaineh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', '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.', 'interventionNames': ['Drug: 0.1 % Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', '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.', 'interventionNames': ['Drug: 0.1% Fluorometholone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', '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.', 'interventionNames': ['Drug: 1% Rimexolone']}], 'interventions': [{'name': '0.1 % Dexamethasone', 'type': 'DRUG', 'otherNames': ['Topical steroid'], 'description': '20 eyes are randomized to receive topical 0.1% Dexamethasone four times per day for 2 weeks.', 'armGroupLabels': ['Group A']}, {'name': '0.1% Fluorometholone', 'type': 'DRUG', 'otherNames': ['Topical steroid'], 'description': '20 eyes are randomized to receive topical 0.1% Fluorometholone four times per day for 2 weeks.', 'armGroupLabels': ['Group B']}, {'name': '1% Rimexolone', 'type': 'DRUG', 'otherNames': ['Topical steroid'], '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', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Omar M. El Shafie El Zawahry, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University Hospital- Department of Ophthalmology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor Abeer Tawfik Farhan Al Hanaineh', 'investigatorFullName': 'Abeer Tawfik Al Hanaineh', 'investigatorAffiliation': 'Cairo University'}}}}