Vision outcomes after PTK-PRK using the CZM MEL 90 excimer laser
Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser for Verification of Predicted Refractive Outcome Using EpiMaster Software Considering Epithelial Remodelling
This project will see if the EpiMaster app's predicted vision results match actual outcomes after PTK-PRK using the CZM MEL 90 laser for people with myopia or myopia plus astigmatism.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | London Vision Clinic Academic / other |
| Locations | 2 sites (Chandigarh, Punjab Haryana and 1 other locations) |
| Trial ID | NCT06996353 on ClinicalTrials.gov |
What this trial studies
This observational investigation collects routine postoperative clinical data from patients who undergo PTK-PRK with the CZM MEL 90 excimer laser and compares those results to preoperative predictions produced by the EpiMaster software. EpiMaster is not used to guide treatment in this project; its predictions are compared retrospectively to clinical refractive outcomes. Inclusion and exclusion follow the CZM MEL 90 user manual, and enrolled patients must be able to consent and complete scheduled follow-up visits. The work is sponsored by London Vision Clinic with Optana GmbH as collaborator and is conducted at participating eye clinics in India.
Who should consider this trial
Good fit: Ideal candidates are adults with myopia (with or without astigmatism) scheduled for PTK-PRK with the CZM MEL 90 laser who can provide informed consent and complete follow-up visits.
Not a fit: Patients with ocular conditions excluded by the CZM MEL 90 user manual or those not undergoing PTK-PRK (including non-myopic refractive errors) are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, this could improve clinicians' ability to predict refractive outcomes after PTK-PRK, leading to more accurate treatment planning and clearer patient expectations.
How similar studies have performed: Prediction tools and nomograms for refractive surgery have shown moderate success, but direct validation of the EpiMaster application specifically for PTK-PRK is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chandigarh, Punjab Haryana and 1 other locations
- Pro Sight Eye Hospital — Chandigarh, Punjab Haryana, India (Recruiting)
- Uma Eye Clinic — Chennai, Tamil Nadu, India (Recruiting)
Study contacts
- Principal investigator: Sheetal Brar, MD — Pro Sight Eye Hospital, Chandigarh, India
- Study coordinator: Timothy Archer, PhD
- Email: timothy@londonvisionclinic.com
- Phone: +44 02072241005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.