Clinical Data Collection of Myopic Patients After PTK-PRK... | NCT06996353

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

NCT06996353

Sponsor

London Vision Clinic

Status

Recruiting

Last Update Posted

Jan 9, 2026Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Refractive Errors

Interventions

PTK-PRK refractive treatment

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 26, 2025Actual

Primary Completion Date

Nov 2026Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

May 21, 2025

First Submission Date that Met QC Criteria

May 21, 2025

First Posted Date

May 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2026

Last Update Posted Date

Jan 9, 2026Actual

Name	Class
Optana GmbH	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The EpiMaster application software is not used in this clinical investigation, consequently, it is a merely observational investigation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PTK-PRK refractive treatment	Procedure	The PTK-PRK refractive treatment will be done according to routine clinical practice.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient present with myopic or myopic and astigmatic error

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Timothy Archer, PhD	Contact	+44 02072241005		timothy@londonvisionclinic.com

Overall Officials

Name	Affiliation	Role
Dan Z Reinstein, MD	London Vision Clinic Ltd., London, United Kingdom	Study Director
Sheetal Brar, MD	Pro Sight Eye Hospital, Chandigarh, India	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pro Sight Eye Hospital	Recruiting	Chandigarh	Punjab Haryana	160043	India

IPD Sharing Statement Module

Plan to Share IPD

Description

The plan is to not share IPD.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided