NCT02700295

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

7.6 years

First QC Date

February 24, 2016

Last Update Submit

April 6, 2022

Conditions

Myopia

Keywords

Orthokeratology

Outcome Measures

Primary Outcomes (2)

  • Quantitative changes in the corneal thickness

    1 year

  • Qualitative changes in the corneal structure

    1 year

Secondary Outcomes (2)

  • Quantitative changes in the choroidal thickness

    1 year

  • Qualitative changes in the choroidal structure

    1 year

Study Arms (1)

Orthokeratology contact lens group

Device: Orthokeratology lens

Interventions

Orthokeratology lensDEVICE
Orthokeratology contact lens group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

10 healthy volunteers

You may qualify if:

  • Men and women aged over 18 years
  • Prospect orthokeratology contact lens wearers
  • Normal findings in the slit lamp examination, no corneal pathologies

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Gerhard Garhöfer, Assoc. Prof. PD Dr

CONTACT

+43 1 4040029810gerhard.garhoefer@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 7, 2016

Study Start

February 1, 2016

Primary Completion

September 1, 2023

Study Completion

September 30, 2023

Last Updated

April 7, 2022

Record last verified: 2022-04

Locations

AU(1)