Outcome and comparison between transepithelial photorefractive keratectomy and photorefractive keratectomy using Manual Superficial keratectomy

Phase 3

Completed

• Conditions: Refractive error requiring refractive surgery; PRK; TransPRK

• Registration Number: TCTR20240806006
• Lead Sponsor: Armed force medical services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-05-01
• Study Start: 2024-08-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. aged 21 to 45 years
2. Normal Slit lamp examination, with no appearing pathology.
3. Spherical equivalent power of -1.0 to -5.0 diopters.
4. Stable refraction with spectacles for the last 12 months before surgery.
5. Normal Pentacam parameters with no suspicious ectasia.
6. The thinnest pachymetry should not be less than 500 microns.
7. The final residual stromal bed thickness should be 400 microns and above including the original epithelium
8. best corrected distance visual acuity of 0.8 Snellen chart or better for each eye.

Exclusion Criteria

1. Eyes with any pre-existing corneal layer pathology (keratoconus, ocular inflammation, glaucoma, past ocular history of any surgery or posterior segment pathology).
2. Medication history of (isotretinoin, amiodarone, anticoagulants, HRT, antihistamine, sumatriptan).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Day 1, 2, 3, 4, and 7 Pain scale 0-10

Secondary Outcome Measures

Name	Time	Method
Photosensitivity Day 1, 2, 3, 4, and 7 Photosensitivity scale 0-10