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

April 6, 2022 updated by: Gerhard Garhofer, Medical University of Vienna
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria
        • Recruiting
        • Center for Medical Physics and Biomedical Engineering, Medical University of Vienna
        • Contact:
          • Gerhard Garhöfer, Assoc. Prof. PD Dr
        • Principal Investigator:
          • Gerhard Garhöfer, Assoc. Prof. PD Dr
        • Sub-Investigator:
          • Wolfgang Drexler, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

10 healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orthokeratology contact lens group
Device: Orthokeratology lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative changes in the corneal thickness
Time Frame: 1 year
1 year
Qualitative changes in the corneal structure
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quantitative changes in the choroidal thickness
Time Frame: 1 year
1 year
Qualitative changes in the choroidal structure
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

September 30, 2023

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (ESTIMATE)

March 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-260514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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