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Treatment of Vision Disturbances Due to Corneal Irregularities by Trans-epithelial Optical Phototherapeutic Keratectomy (TE-oPTK)

NCT03841253 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-02-12

No results posted yet for this study

Summary

This study sets out to evaluate the EpiMaster application software for use in predicting the refractive change induced by a trans-epithelial phototherapeutic keratectomy (TE-PTK) procedure in eyes with irregularly irregular astigmatism. If validation criteria are met during the observational phase, the software refractive prediction will be used to plan the refractive correction in TE-PTK treatments.

Conditions

  • Corneal Astigmatism

Interventions

PROCEDURE

Trans-epithelial PTK

The MEL 90 excimer laser will be used to ablate the corneal epithelium and stroma to a pre-defined depth, using the epithelium as a natural masking agent to smooth the stromal surface.

PROCEDURE

Trans-epithelial PTK (retrospective data collection)

The MEL 90 excimer laser will be used to ablate the corneal epithelium and stroma to a pre-defined depth, using the epithelium as a natural masking agent to smooth the stromal surface.

PROCEDURE

EpiMaster Application Software

The EpiMaster Application Software imports epithelial thickness data and corneal front surface topography data, and uses this to calculate the refractive change that would be induced by a trans-epithelial PTK treatment.

Sponsors & Collaborators

  • Optana GmbH

    collaborator OTHER

  • London Vision Clinic

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2028-03-01
Completion
2028-11-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03841253 on ClinicalTrials.gov