Refractive Errors
Conditions
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 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.
Interventions
PROCEDUREPTK-PRK refractive treatment
The PTK-PRK refractive treatment will be done according to routine clinical practice.
Sponsors
Optana GmbH
London Vision Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of SE(measured) and SE(predicted by EpiMaster) | 6 months | Percentage of eyes with SE6 months post-op measured - SEpredicted by EpiMaster within ±1.00D, with SE being the spherical equivalent |
Countries
India
Contacts
Primary ContactTimothy Archer, PhD
Outcome results
None listed