Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-07 @ 11:03 PM
Study NCT ID:
NCT03097302
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2017-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tomographic Analysis of Anterior, Posterior, Total Corneal Refractive Power Changes After Laser-assisted Keratotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-24', 'studyFirstSubmitDate': '2017-03-18', 'studyFirstSubmitQcDate': '2017-03-24', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Total corneal refractive power at 3 months', 'timeFrame': 'Before and 3 months after lens surgery', 'description': 'Total corneal astigmatism (anterior and posterior astigmatism)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Anterior corneal astigmatism at 3 months', 'timeFrame': 'Before and 3 months after lens surgery', 'description': 'Anterior corneal astigmatism'}, {'measure': 'Change from Baseline Posterior corneal astigmatism at 3 months', 'timeFrame': 'Before and 3 months after lens surgery', 'description': 'Posterior corneal astigmatism'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laser-assisted keratotomy', 'anterior astigmatism', 'posterior astigmatism', 'total corneal refractive power', 'nomogram'], 'conditions': ['Corneal Astigmatism']}, 'descriptionModule': {'briefSummary': 'To analyze the effect of femtolaser-assisted keratotomy on corneal astigmatism (anterior, posterior and Total corneal refractive power) measured by Scheimpflug tomography after laser lens surgery.', 'detailedDescription': "This study investigated patients' eyes with low to moderate total corneal refractive power determined with Scheimpflug tomography (Pentacam HR) after penetrating femtosecond laser-assisted keratotomy (pFLAK) and laser lens surgery. The anterior corneal astigmatism, posterior corneal astigmatism and total corneal refractive power were determined before, 1 month and 3 months after lens surgery. Vector analysis according to the Alpins' method was used to calculate surgically induced astigmatism (SIA)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism during lens surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism\n\nExclusion Criteria:\n\n* Eyes with irregular corneal astigmatism such as keratoconus, previous corneal surgery, acute or chronic ophthalmic diseases of the anterior segment and intraoperative complications were not included in this study.'}, 'identificationModule': {'nctId': 'NCT03097302', 'briefTitle': 'Tomographic Analysis of Anterior, Posterior, Total Corneal Refractive Power Changes After Laser-assisted Keratotomy', 'organization': {'class': 'OTHER', 'fullName': 'University Clinic Frankfurt'}, 'officialTitle': 'Tomographic Analysis of Anterior, Posterior and Total Corneal Refractive Power Changes After Femtosecond Laser-assisted Keratotomy After Laser Lens Surgery', 'orgStudyIdInfo': {'id': '140/13'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Laser keratotomy', 'type': 'PROCEDURE', 'description': 'Penetrating femtosecond laser assisted keratotomy to treat preexisting corneal astigmatism during lens surgery.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Via a Publication in a reviewed journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Clinic Frankfurt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med. Thomas Kohnen', 'investigatorFullName': 'Myriam Böhm', 'investigatorAffiliation': 'University Clinic Frankfurt'}}}}