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NCT02700295 Clinical Trial

Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study

Myopia Clinical Trial

Official title:
Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02700295
Other study ID # OPHT-260514
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2016
Est. completion date September 30, 2023

Study information
Verified date April 2022
Source Medical University of Vienna
Contact Gerhard Garhöfer, Assoc. Prof. PD Dr
Phone +43 1 4040029810
Email gerhard.garhoefer@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Orthokeratology has the benefit for slowing down myopia progression and enabling unaided vision during the day. To investigate proposed possible changes of conventional and multifocal orthokeratology in the cornea and choroid this study will image both structures with high resolution optical coherence tomographs over a six month period. Findings will help to plan larger trials over a longer period of time in adults and teenagers.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date September 30, 2023
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Men and women aged over 18 years - Myopia defined as between -1D and -6 D with an increase of 0.5D within the last 18months prior to inclusion - Prospect orthokeratology contact lens wearers - Normal findings in the slit lamp examination, no corneal pathologies Exclusion Criteria: - Participation in a clinical trial in the previous 3 weeks - Presence of any abnormalities (such as refractive surgery) preventing reliable measurements as judged by the investigator - Current contact lens wearers - Pregnancy, planned pregnancy or lactating

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Orthokeratology lens

Locations
Country Name City State
Austria Center for Medical Physics and Biomedical Engineering, Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quantitative changes in the corneal thickness 1 year
Primary Qualitative changes in the corneal structure 1 year
Secondary Quantitative changes in the choroidal thickness 1 year
Secondary Qualitative changes in the choroidal structure 1 year
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