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

Refractive Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05060094
• Other study ID #: outcomes of TransPRK
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: June 5, 2018

Study information

• Verified date: September 2021
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 5, 2018
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractive Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aberrations	ocular high-order aberrations including spherical, coma and trefoil aberrations were measured by OPD-Scan II	2016.03.01-2018.06.05
Secondary	contrast sensitivity	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
Secondary	haze	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
Secondary	postoperative pain	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