Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-06 @ 1:34 PM
Study NCT ID:
NCT01140594
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2010-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wavefront-guided Photorefractive Keratectomy (PRK) Versus Wavefront-guided Lasik for Myopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018903', 'term': 'Photorefractive Keratectomy'}, {'id': 'D020731', 'term': 'Keratomileusis, Laser In Situ'}], 'ancestors': [{'id': 'D048988', 'term': 'Corneal Surgery, Laser'}, {'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000074431', 'term': 'Keratectomy'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-03', 'studyFirstSubmitDate': '2010-06-02', 'studyFirstSubmitQcDate': '2010-06-08', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in uncorrected visual acuity', 'timeFrame': 'Baseline to one year'}, {'measure': 'Changes in best spectacle corrected visual acuity', 'timeFrame': 'Baseline to one year'}, {'measure': 'Changes in 25 and 5% low contrast acuity', 'timeFrame': 'baseline to one year'}], 'secondaryOutcomes': [{'measure': 'Changes in quality of vision', 'timeFrame': 'baseline to one year'}, {'measure': 'Comparison of dry eye signs and symptoms between LASIK and PRK', 'timeFrame': 'baseline to one year'}, {'measure': 'Changes in higher order aberrations', 'timeFrame': 'Baseline to one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia', 'Astigmatism']}, 'referencesModule': {'references': [{'pmid': '22253488', 'type': 'RESULT', 'citation': 'Manche EE, Haw WW. Wavefront-guided laser in situ keratomileusis (Lasik) versus wavefront-guided photorefractive keratectomy (Prk): a prospective randomized eye-to-eye comparison (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2011 Dec;109:201-20.'}]}, 'descriptionModule': {'briefSummary': 'A prospective comparison of eyes undergoing wavefront-guided LASIK in one eye and wavefront-guided PRK in their fellow eye for myopia.', 'detailedDescription': "This is a research study comparing the outcomes of LASIK surgery to PRK surgery for nearsightedness when using the two different procedures. You will have one eye treated with LASIK using the Intralase FS laser and your other eye treated with PRK. You will be one of 100 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 200 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) in one eye and photorefractive keratectomy (PRK) in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives LASIK and which eye receives PRK will be randomized prior to enrollment. Randomization will be done according to a randomization schedule. You will know which eye is being treated with which procedure. The randomization will determine only whether your right or left eye is treated with the LASIK procedure. The other eye will be treated with PRK. You have a fifty percent chance of having your left eye treated with LASIK as your right eye. Subjects will undergo either bilateral (both eyes at once) wavefront (a more precise custom laser system) guided LASIK and PRK treatments using the VISX Star S4 excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo LASIK and PRK for the correction of myopia (nearsightedness) with or without astigmatism will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, subjects will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Retreatments (a second operation on the same eye for residual nearsightedness) will not be allowed during the first six months of this study. If you elect to undergo a retreatment of your LASIK or PRK surgery prior to the 6-month post-operative visit, the retreated eye will be exited from the study as of the retreatment date.\n\nAny significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects age 21 and older with healthy eyes.\n* Nearsightedness between -0.75 diopters and -7.00 diopters with or without astigmatism of up to -3.50 diopters.\n\nExclusion Criteria:\n\n* Subjects under the age of 21.\n* Patients with thin corneas.\n* Patients with topographic irregularities.\n* Patients with keratoconus.\n* Patients with autoimmune diseases.\n* Patients who are pregnant or nursing.\n* Patients must have similar levels of nearsightedness in each eye. They can not be more than 1.0 diopter of difference between eyes.\n* Patients must have similar levels of astigmatism in each eye. They can not have more than 1.0 diopter of difference between eyes.'}, 'identificationModule': {'nctId': 'NCT01140594', 'briefTitle': 'Wavefront-guided Photorefractive Keratectomy (PRK) Versus Wavefront-guided Lasik for Myopia', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Prospective Randomized Eye to Eye Comparison of Fellow Eyes Undergoing Lasik With the IntraLase(TM) FS Versus PRK', 'orgStudyIdInfo': {'id': 'SU-05192010-6082'}, 'secondaryIdInfos': [{'id': 'SQL 97234'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wavefront-guided PRK', 'description': 'Wavefront-guided PRK', 'interventionNames': ['Procedure: Photorefractive keratectomy', 'Procedure: Laser in-situ keratomileusis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wavefront-guided LASIK', 'description': 'Wavefront-guided LASIK', 'interventionNames': ['Procedure: Photorefractive keratectomy', 'Procedure: Laser in-situ keratomileusis']}], 'interventions': [{'name': 'Photorefractive keratectomy', 'type': 'PROCEDURE', 'otherNames': ['PRK, CustomVue, Wavefront-guided'], 'description': 'One eye undergoes wavefront-guided PRK with the Visx S4 CustomVue excimer laser.', 'armGroupLabels': ['Wavefront-guided LASIK', 'Wavefront-guided PRK']}, {'name': 'Laser in-situ keratomileusis', 'type': 'PROCEDURE', 'otherNames': ['LASIK, CustomVue, Visx, Intralase FS60'], 'description': 'One eye undergoes wavefront-guided LASIK using the Visx S4 excimer laser.', 'armGroupLabels': ['Wavefront-guided LASIK', 'Wavefront-guided PRK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Edward E. Manche', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology', 'investigatorFullName': 'Edward E. Manche', 'investigatorAffiliation': 'Stanford University'}}}}