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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02700295
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 91.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Orthokeratology lens

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study
• Study Start Date: Feb 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Orthokeratology contact lens group	Device: Orthokeratology lens

Outcome Measures

Primary Outcome Measures

1. Quantitative changes in the corneal thickness [1 year]

2. Qualitative changes in the corneal structure [1 year]

Secondary Outcome Measures

1. Quantitative changes in the choroidal thickness [1 year]

2. Qualitative changes in the choroidal structure [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Medical Physics and Biomedical Engineering, Medical University of Vienna	Vienna		Austria

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerhard Garhofer, MD, PhD, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT02700295
• Other Study ID Numbers: OPHT-260514
• First Posted: Mar 7, 2016
• Last Update Posted: Apr 7, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by Gerhard Garhofer, MD, PhD, Medical University of Vienna: Orthokeratology
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Apr 7, 2022