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

Comparison of Outcomes Between Single-step Transepithelial Photorefractive Keratectomy and Off-flap Epipolis Laser in Situ Keratomileusis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05060094
Enrollment
38
Registered
2021-09-28
Start date
2016-03-01
Completion date
2018-06-05
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Surgery

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.

Interventions

None listed

Sponsors

Wenzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 38 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
aberrations2016.03.01-2018.06.05ocular high-order aberrations including spherical, coma and trefoil aberrations were measured by OPD-Scan II

Secondary

MeasureTime frameDescription
contrast sensitivity2016.03.01-2018.06.05contrast 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
haze2016.03.01-2018.06.05Corneal 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.
postoperative pain2016.03.01-2018.06.05Subjective 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026