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

NCT ID: NCT02700295

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2023-09-30

Brief Summary

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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

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Conditions

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Myopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Orthokeratology contact lens group

Orthokeratology lens

Intervention Type DEVICE

Interventions

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Orthokeratology lens

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Medical Physics and Biomedical Engineering, Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Gerhard Garhöfer, Assoc. Prof. PD Dr

Role: CONTACT

+43 1 4040029810

Facility Contacts

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Gerhard Garhöfer, Assoc. Prof. PD Dr

Role: primary

Other Identifiers

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OPHT-260514

Identifier Type: -

Identifier Source: org_study_id

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