Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser
ConditionRefractive Errors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLondon Vision Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Exclusion criteria are according to the user manual of CZM MEL 90 Excimer Laser for treatment of refractive errors
Trial population
Patient present with myopic or myopic and astigmatic error
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
PTK-PRK refractive treatment
Procedure/SurgeryThe PTK-PRK refractive treatment will be done according to routine clinical practice.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
6 monthsSponsors and contacts
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London Vision Clinic
Lead sponsor
Optana GmbH
Collaborator
Source ClinicalTrials.gov