Refractive ErrorsNCT06996353
Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser
An observational study of Refractive Errors, run by London Vision Clinic at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refractive Errors
- What is being tested?
- PTK-PRK refractive treatment
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 2 sitesIndia
- Study dates
- 26 May 2025to Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient present with myopic or myopic and astigmatic error
Who may be able to join
- 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
Who cannot join
- Exclusion criteria are according to the user manual of CZM MEL 90 Excimer Laser for treatment of refractive errors
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
Pro Sight Eye Hospital
Chandigarh, Punjab Haryana, 160043
Sheetal Brar, Medical Director, MD, +91 91159 00661, prosightchandigarh@gmail.com
Sheetal Brar, MD
- Recruiting
Uma Eye Clinic
Chennai, Tamil Nadu, 600040
Aadithreya Varman, MD, +91 44 4902 3232, info@umaeyeclinic.in
Aadithreya Varman, MD, Director of Uma Eye Clinic
About this study
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
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.
Read the 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.
- Conditions
- Refractive Errors
- Being tested
- PTK-PRK refractive treatment
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTK-PRK refractive treatmentProcedure or surgery
The PTK-PRK refractive treatment will be done according to routine clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start26 May 2025
- Primary completionNov 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Vision Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Optana GmbH
- Responsible party
- Sponsor
- Investigators
- Dan Z Reinstein, MD, Study director, London Vision Clinic Ltd., London, United KingdomSheetal Brar, MD, Principal investigator, Pro Sight Eye Hospital, Chandigarh, IndiaAadithreya Varman, MD, Principal investigator, Uma Eye Clinic, Chennai, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996353
- Sponsor's protocol ID
- LoVC-011
- Status last verified
- Jan 2026
- First submitted
- 21 May 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to not share IPD.