Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 5:39 AM
Study NCT ID:
NCT05060094
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Outcomes Between TransPRK and Off-flap Epi-LASIK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-17', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'aberrations', 'timeFrame': '2016.03.01-2018.06.05', 'description': 'ocular high-order aberrations including spherical, coma and trefoil aberrations were measured by OPD-Scan II'}], 'secondaryOutcomes': [{'measure': 'contrast sensitivity', 'timeFrame': '2016.03.01-2018.06.05', 'description': 'contrast sensitivity and contrast sensitivity under glare condition measurements were performed by the CSV-1000E which could test four spatial frequencies: 3,6,12 and 18 cycles/degree (cpd) at 2.5m. The contrast sensitivity was measured under photopic (596.7cd/㎡) and scotopic (0.01cd/㎡) conditions and the contrast sensitivity under glare condition was taken under scotopic condition with glare'}, {'measure': 'haze', 'timeFrame': '2016.03.01-2018.06.05', 'description': "Corneal haze grade was recorded according to Fantes's report: 0, no haze; 0.5, trace haze only could be seen by oblique illumination; 1,more visible haze not interfering with the visibility of iris details; 2, mild influence of iris details; 3, moderate influence of iris details; 4, marked haze obscuring the stroma of ablation area."}, {'measure': 'postoperative pain', 'timeFrame': '2016.03.01-2018.06.05', 'description': 'Subjective pain scores were evaluated on the third day according to a predetermined scale ranging from 0 to 5 as follows: 0, no pain or discomfort; 1, photophobia and tears; 2, photophobia and tears with mild pain; 3, photophobia and tears with moderate pain that does not require oral medication; 4, photophobia and tears with severe pain that oral medication can relieve; 5, photophobia and tears with severe pain that oral medication cannot relieve.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractive Surgery']}, 'referencesModule': {'references': [{'pmid': '35606707', 'type': 'DERIVED', 'citation': 'Zhang Y, Li T, Li Z, Dai M, Wang Q, Xu C. Clinical outcomes of single-step transepithelial photorefractive keratectomy and off-flap epipolis-laser in situ keratomileusis in moderate to high myopia: 12-month follow-up. BMC Ophthalmol. 2022 May 23;22(1):234. doi: 10.1186/s12886-022-02443-6.'}]}, 'descriptionModule': {'briefSummary': 'To compare the quantitative and qualitative optical outcomes between single-step transepithelial photorefractive keratectomy (TransPRK) and off-flap epipolis laser in situ keratomileusis (Epi-LASIK) in moderate to high myopia.we included patients with moderate to high myopia who were randomized to have TransPRK in one eye and Epi-LASIK in the other eye. All patients underwent comprehensive ophthalmological examinations, including uncorrected (UDVA) and corrected distance visual acuities (CDVA), manifest refraction, intraocular pressure, anterior and posterior segment examination, corneal topography measured by Scheimpflug scanning-slit topographer (Pentacam, Oculus Optikgerate GmbH), contrast sensitivity (CS) under photopic and mesopic conditions (CSV-1000E, Vector Vision Inc., Greenville, OH, USA) with correction by spectacles, ocular wavefront aberrometry (OPD-Scan II, Nidek Co. Ltd). At each follow-up, CS and aberration measures were repeated 3 times and the average value was analyzed. Optical parameters were repeated 1, 3, 6, and 12 months after surgery.Statistical analysis was performed using SPSS software (version 22.0, SPSS, Chicago, Inc.). Kolmogorov-Smirnov test was used to check the normal distribution of variables. Student t-test or Wilcoxon rank sum test was used based on the normality of data. A P value less than 0.05 was considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'people accepted refractive surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 years\n* corrected distance visual acuity (CDVA) in logarithm of minimal angle of resolution (LogMAR) of 0.10 or better\n* refractive error stabilized for at least 1 year\n* discontinued contact lens use for at least 2 weeks\n\nExclusion Criteria:\n\n* presence of corneal scars\n* keratoconus\n* glaucoma\n* retinal diseases\n* a history of corneal or intraocular surgery'}, 'identificationModule': {'nctId': 'NCT05060094', 'briefTitle': 'Comparison of Outcomes Between TransPRK and Off-flap Epi-LASIK', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Comparison of Outcomes Between Single-step Transepithelial Photorefractive Keratectomy and Off-flap Epipolis Laser in Situ Keratomileusis', 'orgStudyIdInfo': {'id': 'outcomes of TransPRK'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of cataract department', 'investigatorFullName': 'Yune Zhao', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}