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Recruiting NCT06996353

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

Observational Refractive Errors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PTK-PRK refractive treatment.
Who it may be relevant to
Registry conditions: Refractive Errors. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Difference of SE(measured) and SE(predicted by EpiMaster) [Time frame: 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

India · 2 centers
  • Pro Sight Eye Hospital — Chandigarh
  • Uma Eye Clinic — Chennai

Identifiers

NCT: NCT06996353 · LoVC-011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗