Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT01296867
Status:
COMPLETED
Last Update Posted:
2011-02-16
First Post:
2011-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Asphericity Adjustment (Q Adjustment) in Myopic and Hyperopic Patients Undergoing Refractive Correction With Excimer Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-15', 'studyFirstSubmitDate': '2011-02-15', 'studyFirstSubmitQcDate': '2011-02-15', 'lastUpdatePostDateStruct': {'date': '2011-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laser ablation algorithms', 'Excimer laser', 'Refractive correction', 'Corneal Asphericity Adjustment'], 'conditions': ['Myopia', 'Hyperopia']}, 'descriptionModule': {'briefSummary': 'To study the postoperative results in myopic and hyperopic eyes treated with two different laser ablation algorithms (STD and F-CAT), both FDA approved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Forty eight myopic (24 patients) and 24 hyperopic eyes (12 patients)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myopic and hyperopic eyes eligible for LASIK or PRK refractive correction\n* Central corneal thickness more than 500 micrometers\n\nExclusion Criteria:\n\n* Topographies of less than 55% of successful total sampled area and eyes exhibiting asphericity variations, in either the horizontal or the vertical axis, greater than 0.2\n* Corneal scarring\n* Cataract surgery\n* Corneal ulceration\n* Topographical abnormalities'}, 'identificationModule': {'nctId': 'NCT01296867', 'briefTitle': 'Corneal Asphericity Adjustment (Q Adjustment) in Myopic and Hyperopic Patients Undergoing Refractive Correction With Excimer Laser', 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'orgStudyIdInfo': {'id': 'Q-value'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Democritus University of Thrace', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Eleftherios Paschalis / PhD', 'oldOrganization': 'Eye Institute of Thrace / Democritus University'}}}}