Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser

Recruiting

• Conditions: Refractive Errors

• Registration Number: NCT06996353
• Lead Sponsor: London Vision Clinic

Brief Summary

The objective of the clinical investigation presented to is to verify predictions of post-operative PTK-PRK refractive outcome made by the EpiMaster application software by comparing these to post-operative clinical data after routine PTK-PRK treatments.

Detailed Description

The objective of the clinical investigation presented to is to verify predictions of post-operative PTK-PRK refractive outcome made by the EpiMaster application software by comparing these to post-operative clinical data after routine PTK-PRK treatments.

The EpiMaster application software is not used in this clinical investigation, consequently, it is a merely observational investigation.

Study Timeline

• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Study Start: 2025-05-26
• Study First Posted: 2025-05-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Primary Completion: 2026-11
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Inclusion criteria are according to the user manual of CZM MEL 90 Excimer Laser for treatment of refractive errors
• Patient present with myopic or myopic and astigmatic error
• Patient will be able to understand the patient information and willing to sign an informed consent
• Patient will be willing to comply with all follow-up visits and the respective examinations

Exclusion Criteria

• Exclusion criteria are according to the user manual of CZM MEL 90 Excimer Laser for treatment of refractive errors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of SE(measured) and SE(predicted by EpiMaster)	6 months	Percentage of eyes with SE6 months post-op "measured" - SEpredicted by EpiMaster within ±1.00D, with SE being the spherical equivalent

Trial Locations

Locations (2)

Pro Sight Eye Hospital; 🇮🇳 Chandigarh, Punjab Haryana, India

Uma Eye Clinic; 🇮🇳 Chennai, Tamil Nadu, India