Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-03 @ 8:23 PM
Study NCT ID:
NCT01506635
Status:
COMPLETED
Last Update Posted:
2012-01-10
First Post:
2012-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After LASIK: a Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013999', 'term': 'Timolol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-09', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spherical Equivalent', 'timeFrame': 'spherical equivalent at month 6', 'description': 'Effect of timolol use in timolol group will be compared with placebo group at month 6. Moreover, the changes of intragroup spherical equivalent will be assessed in both group 6 months after timolol application.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Myopic Regression']}, 'referencesModule': {'references': [{'pmid': '22935601', 'type': 'DERIVED', 'citation': 'Shojaei A, Eslani M, Vali Y, Mansouri M, Dadman N, Yaseri M. Effect of timolol on refractive outcomes in eyes with myopic regression after laser in situ keratomileusis: a prospective randomized clinical trial. Am J Ophthalmol. 2012 Nov;154(5):790-798.e1. doi: 10.1016/j.ajo.2012.05.013. Epub 2012 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'In this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after LASIK'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with myopic regression equal or more than 0.5 D with minimum age of 20 years,\n* cylinder ≤ -1.00 D,\n* corrected distance visual acuity (CDVA) of at least 20/40 were included.\n\nExclusion Criteria:\n\n* Patients with a history of previous ocular surgery,\n* keratoconus or any ectatic corneal disorder,\n* keratoconus suspect by topography,\n* preoperative corneal opacity,\n* any corneal dystrophies,\n* presence of pterygium,\n* retinal disorders,\n* collagen vascular disorders,\n* diabetes mellitus,\n* glaucoma,\n* cataract,\n* pregnancy,\n* breast feeding\n* systemic corticosteroid therapy were excluded.'}, 'identificationModule': {'nctId': 'NCT01506635', 'briefTitle': 'Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After LASIK: a Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After Laser in Situ Keratomileusis: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '8902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'included patients who received artificial tear twice a day as control group.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Timolol group', 'description': 'included the patients with myopic regression who received timolol 0.5% eye drop twice a day', 'interventionNames': ['Drug: Timolol']}], 'interventions': [{'name': 'Timolol', 'type': 'DRUG', 'armGroupLabels': ['Timolol group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'artificial tear twice a day', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16666', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Ophthalmic Research Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}}}}