Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-02 @ 7:55 AM
Study NCT ID:
NCT00412295
Status:
WITHDRAWN
Last Update Posted:
2025-07-23
First Post:
2006-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Alcon Ladarvision Wavefront-Guided PRK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of resources and not because of any concern with the safety or effectiveness of the procedures studied.', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2006-12-15', 'studyFirstSubmitQcDate': '2006-12-15', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corrected distance visual acuity (CDVA)', 'timeFrame': '12 months', 'description': 'CDVA (logMAR unit and/or snellen equivalent) will be measured to determine safety of wavefront guided PRK.'}, {'measure': 'Uncorrected distance visual acuity (UDVA)', 'timeFrame': '12 months', 'description': 'UDVA (logMAR unit and/or snellen equivalent) will be measured to determine effectiveness of wavefront guided PRK.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Naturally occuring myopia with or without astigmatism.', 'Wavefront errors'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\n1. determine the safety of wavefront guided PRK\n2. evaluate the efficacy of wavefront guided PRK\n3. evaluate the differences in visual quality after treatment of wavefront guided PRK'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects will be recruited from those active duty soldiers that have requested refractive surgery. Subjects must be eligible for medical care at WRAMC.\n* Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.\n* Manifest refractive spherical equivalent (MSE) of up to -6 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.\n* At least five images must be capturesd in both eyes (dilated) with a pupil size of at least 7mm.\n* Manifest refraction and LADARWave™ refractions must be within 1.00 D and the CustomCornea® software must allow for treatment with a 6.5mm minor axis and 9mm ablation zone.\n* Best spectacle corrected visual acuity of 20/20 or better in both eyes.\n* Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination, sa confirmed by clinical records.\n* Soft contact lens users must have removed their lenses at least 2 weeks before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements adn have 2 central Keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50D in either meridian; mires should be regular.\n* Located it the greater Washington DC Area for a 12-month period.\n* Exhibits strong motivation for attending the follow-up visits.\n* Consent of the subject's command (active duty) to participate in the study.\n* Access to transportation to meet follow-up requirements.\n\nExclusion Criteria:\n\n* Female subjects who are pregnant, breast feeding or intend to become pregnant during the study.\n* Concurrent topical or systemic medications that may impair healing, including corticosteriods, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.\n* Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular diseases and ocular herpes zoster or simplex.\n* Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.\n* Evidence of glaucoma or an intraocular pressure greater than 22mm Hg at baseline.\n* Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.\n* History of recurrent erosions or epithelial baewsment dystrophy.\n* Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.\n* Any physical or mental impairment that would preclude participation in any of the examinations."}, 'identificationModule': {'nctId': 'NCT00412295', 'briefTitle': 'Evaluation of Alcon Ladarvision Wavefront-Guided PRK', 'organization': {'class': 'FED', 'fullName': 'Walter Reed Army Medical Center'}, 'officialTitle': 'Evaluation of Alcon Ladarvision Wavefront-Guided PRK', 'orgStudyIdInfo': {'id': 'WRAMC WU#04-23006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Wavefront-guided PRK', 'interventionNames': ['Device: Alcon Ladarvision (Wavefront-guided PRK)']}], 'interventions': [{'name': 'Alcon Ladarvision (Wavefront-guided PRK)', 'type': 'DEVICE', 'description': 'Wavefront-guided PRK using Alcon Ladarvision', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92134', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20307', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center, Center For Refractive Surgery', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'STEVEN SCHALLHORN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Naval Medical Center, San Diego'}, {'name': 'KRAIG S BOWER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walter Reed Army Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed Army Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PRS Account holder', 'investigatorFullName': 'Samantha B. Rodgers, MD', 'investigatorAffiliation': 'Walter Reed Army Medical Center'}}}}