- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060094
Comparison of Outcomes Between TransPRK and Off-flap Epi-LASIK
September 17, 2021 updated by: Yune Zhao, Wenzhou Medical University
Comparison of Outcomes Between Single-step Transepithelial Photorefractive Keratectomy and Off-flap Epipolis Laser in Situ Keratomileusis
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
38
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
people accepted refractive surgery
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- presence of corneal scars
- keratoconus
- glaucoma
- retinal diseases
- a history of corneal or intraocular surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
aberrations
Time Frame: 2016.03.01-2018.06.05
|
ocular high-order aberrations including spherical, coma and trefoil aberrations were measured by OPD-Scan II
|
2016.03.01-2018.06.05
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
contrast sensitivity
Time Frame: 2016.03.01-2018.06.05
|
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
|
2016.03.01-2018.06.05
|
haze
Time Frame: 2016.03.01-2018.06.05
|
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.
|
2016.03.01-2018.06.05
|
postoperative pain
Time Frame: 2016.03.01-2018.06.05
|
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.
|
2016.03.01-2018.06.05
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
June 5, 2018
Study Registration Dates
First Submitted
September 17, 2021
First Submitted That Met QC Criteria
September 17, 2021
First Posted (Actual)
September 28, 2021
Study Record Updates
Last Update Posted (Actual)
September 28, 2021
Last Update Submitted That Met QC Criteria
September 17, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- outcomes of TransPRK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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