Comparison of Outcomes Between TransPRK and Off-flap Epi-LASIK

NCT ID: NCT05060094

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2018-06-05

Brief Summary

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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.

Detailed Description

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Conditions

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Refractive Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

director of cataract department

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 35606707 (View on PubMed)

Other Identifiers

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outcomes of TransPRK

Identifier Type: -

Identifier Source: org_study_id

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