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

• Conditions: Myopia

• Registration Number: NCT02700295
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07
• Primary Completion: 2023-09
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative changes in the corneal thickness	1 year
Qualitative changes in the corneal structure	1 year

Secondary Outcome Measures

Name	Time	Method
Quantitative changes in the choroidal thickness	1 year
Qualitative changes in the choroidal structure	1 year

Trial Locations

Locations (1)

Center for Medical Physics and Biomedical Engineering, Medical University of Vienna; 🇦🇹 Vienna, Austria