Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT01183702
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2010-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corneal Biomechanics With Hydration in Normal and LASIK Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2010-08-13', 'studyFirstSubmitQcDate': '2010-08-13', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal hydration (swelling)', 'timeFrame': 'Two hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LASIK vs. non-LASIK'], 'conditions': ['Laser Corneal Surgery']}, 'descriptionModule': {'briefSummary': 'The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas.', 'detailedDescription': "The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas. Subjects' corneas will be swelled with warmed, humidified nitrogen using modified diving goggles to assess structural changes due to a two hour swelling period. Subjects will be examined prior to swelling by a registered ophthalmologist to ensure that the cornea is healthy enough to undergo the swelling procedure. Pre-swelling and post-swelling data will be compared for parameters such as elasticity, density, thickness, axial and tangential curvature, hydration, and intraocular pressure in the central, paracentral, and peripheral regions. Analysis of pre-swelling and post-swelling data will allow for a better understanding of the structural changes created by LASIK. In addition, this project will allow for a better understanding of how common fluctuations in hydration levels affect normal corneal parameters as given by common devices in both populations to allow for corrections for more accurate measurements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy cornea without LASIK surgery as determined by a registered ophthalmologist.\n* Healthy cornea with LASIK surgery as determined by a registered ophthalmologist.\n\nExclusion Criteria:\n\n* Children under 18.\n* Unhealthy cornea as determined by a registered ophthalmologist.'}, 'identificationModule': {'nctId': 'NCT01183702', 'briefTitle': 'Corneal Biomechanics With Hydration in Normal and LASIK Eyes', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Analysis of Corneal Biomechanics Based Upon Central and Peripheral Corneal Thickness in Normal and Post Refractive Surgery Eyes', 'orgStudyIdInfo': {'id': '2004H002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'non-LASIK', 'description': 'These participants have NOT had LASIK surgery.', 'interventionNames': ['Other: No Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LASIK', 'description': 'These participants have had LASIK surgery.', 'interventionNames': ['Procedure: LASIK surgery']}], 'interventions': [{'name': 'LASIK surgery', 'type': 'PROCEDURE', 'otherNames': ['Refractive Surgery'], 'description': 'Participants have received LASIK surgery and their eyes are healthy.', 'armGroupLabels': ['LASIK']}, {'name': 'No Intervention', 'type': 'OTHER', 'otherNames': ['Normal cornea', 'no refractive surgery'], 'description': 'Participant has healthy eyes not altered by LASIK surgery.', 'armGroupLabels': ['non-LASIK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ophthalmology Department (Gowdy Field Building, 5th Floor)', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Deborah M Grzybowski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deb Grzybowski', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Research Professor', 'investigatorFullName': 'Deb Grzybowski', 'investigatorAffiliation': 'Ohio State University'}}}}