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

TRANSEPITHELIAL VERSUS CONVENTIONAL PHOTOREFRACTIVE KERATECTOMY. VISUAL RECOVERY, SPHERICAL ABERRATION AND DENSITOMETRY: A RANDOMIZED CONTROL TRIAL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240806006
Enrollment
76
Registered
2024-08-06
Start date
2022-12-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Refractive error requiring refractive surgery PRK TransPRK

Interventions

trans epithelial PEK using excimer laser,PRK after Manual epithelial removal
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
tPRK,mPRK

Sponsors

Armed force medical services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 45 Years

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Pain Day 1, 2, 3, 4, and 8 Pain scale 0-10,Photophobia Day 8, and 1, 3, 6 months Pain scale 0-10,Corneal epithelial healing Day 1, 4 and 8 Slit lamb examination, percentage out of 100% compared to initial defect

Secondary

MeasureTime frame
Distance uncorrected vision Day 8, and 1, 3, 6 months Snellen Chart ,Spherical aberration Pre op, and 1, 3, 6 months Pentacam,Corneal densitometry Pre Op, 1, 3, 6 months Pentacam

Countries

Oman

Contacts

Public ContactMojahid Al Kalbani

Oman medical speciality board

msaKalbani@gmail.com00968 92454232

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026