Comparison of Outcomes Between TransPRK and Off-flap Epi-LASIK
1 other identifier
observational
38
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2016
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2018
CompletedFirst Submitted
Initial submission to the registry
September 17, 2021
CompletedFirst Posted
Study publicly available on registry
September 28, 2021
CompletedSeptember 28, 2021
September 1, 2021
1 year
September 17, 2021
September 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
aberrations
ocular high-order aberrations including spherical, coma and trefoil aberrations were measured by OPD-Scan II
2016.03.01-2018.06.05
Secondary Outcomes (3)
contrast sensitivity
2016.03.01-2018.06.05
haze
2016.03.01-2018.06.05
postoperative pain
2016.03.01-2018.06.05
Eligibility Criteria
people accepted refractive surgery
You may qualify if:
- age over 18 years
- corrected distance visual acuity (CDVA) in logarithm of minimal angle of resolution (LogMAR) of 0.10 or better
- refractive error stabilized for at least 1 year
- discontinued contact lens use for at least 2 weeks
You may not qualify if:
- presence of corneal scars
- keratoconus
- glaucoma
- retinal diseases
- a history of corneal or intraocular surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 35606707DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of cataract department
Study Record Dates
First Submitted
September 17, 2021
First Posted
September 28, 2021
Study Start
March 1, 2016
Primary Completion
March 1, 2017
Study Completion
June 5, 2018
Last Updated
September 28, 2021
Record last verified: 2021-09