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

NCT06996353 | Recruiting

• 1 other identifier: LoVC-011
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

• Difference of SE(measured) and SE(predicted by EpiMaster)

  Percentage of eyes with SE6 months post-op "measured" - SEpredicted by EpiMaster within ±1.00D, with SE being the spherical equivalent

  6 months

Interventions

PTK-PRK refractive treatment PROCEDURE

The PTK-PRK refractive treatment will be done according to routine clinical practice.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient present with myopic or myopic and astigmatic error

You may qualify if:

• 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

Sponsors & Collaborators

• London Vision Clinic: lead
• Optana GmbH: collaborator

Study Sites (2)

Pro Sight Eye Hospital

Chandigarh, Punjab Haryana, 160043, India

RECRUITING

Uma Eye Clinic

Chennai, Tamil Nadu, 600040, India

RECRUITING

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Dan Z Reinstein, MD

  London Vision Clinic Ltd., London, United Kingdom

  STUDY DIRECTOR

• Sheetal Brar, MD

  Pro Sight Eye Hospital, Chandigarh, India

  PRINCIPAL INVESTIGATOR

• Aadithreya Varman, MD

  Uma Eye Clinic, Chennai, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Archer, PhD

CONTACT

+44 02072241005; timothy@londonvisionclinic.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)