Actively Recruiting
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
Led by London Vision Clinic · Updated on 2026-01-09
150
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
Sponsors
L
London Vision Clinic
Lead Sponsor
O
Optana GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to verify the accuracy of the EpiMaster application software's predictions for post-operative results in patients undergoing PTK-PRK refractive treatments. The study focuses on people with myopic or myopic and astigmatic refractive errors and compares predicted outcomes with actual clinical data after surgery. This observational study does not use the EpiMaster software during treatment but collects data to assess its prediction capabilities. Participants will receive PTK-PRK refractive treatment following routine clinical practice using the CZM MEL 90 Excimer Laser. The study does not involve any experimental procedures or interventions beyond standard care. The aim is to gather postoperative data to evaluate how well the software predicts the refractive outcomes, considering epithelial remodeling. During the study, participants will undergo follow-up visits and examinations as part of their routine care and data collection. Researchers will measure the difference between the spherical equivalent (SE) measured after surgery and the SE predicted by the EpiMaster software, with the primary outcome assessed at six months post-treatment. Participants need to agree to attend all follow-ups and understand the study information before enrolling. The study is expected to continue until mid-2027.
CONDITIONS
Brief Title
Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Inclusion criteria follow the user manual of CZM MEL 90 Excimer Laser for treating refractive errors
- Patient has myopic or myopic and astigmatic refractive error
- Patient can understand the study information and is willing to sign informed consent
- Patient agrees to comply with all follow-up visits and examinations
You will not qualify if you...
- Exclusion criteria follow the user manual of CZM MEL 90 Excimer Laser for treating refractive errors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo routine PTK-PRK refractive treatment with standard post-operative care.
1 visit (in-person)
Duration - 6 months
Participants are observed through follow-up visits to collect clinical data after the PTK-PRK treatment.
Multiple follow-up visits over 6 months
Trial Site Locations
Total: 2 locations
1
Pro Sight Eye Hospital
Chandigarh, Punjab Haryana, India, 160043
Actively Recruiting
2
Uma Eye Clinic
Chennai, Tamil Nadu, India, 600040
Actively Recruiting
Research Team
T
Timothy Archer, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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