MyopiaNCT02700295
Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study
An observational study of Myopia, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Orthokeratology lens
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2016to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Center for Medical Physics and Biomedical Engineering, Medical University of Vienna
Vienna
Gerhard Garhöfer, Assoc. Prof. PD Dr
Gerhard Garhöfer, Assoc. Prof. PD Dr
About this study
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.
- Conditions
- Myopia
- Being tested
- Orthokeratology lens
- Keywords
- Orthokeratology
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthokeratology lensDevice
| Study group | Role | What they receive |
|---|---|---|
| Orthokeratology contact lens group | Not described Receives: Device: Orthokeratology lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative changes in the corneal thickness
Measured: 1 year
Qualitative changes in the corneal structure
Measured: 1 year
Secondary outcomes (2)
Quantitative changes in the choroidal thickness
Measured: 1 year
Qualitative changes in the choroidal structure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700295
- Sponsor's protocol ID
- OPHT-260514
- Status last verified
- Apr 2022
- First submitted
- 24 Feb 2016
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study
- ClinicalTrials.gov ID
- NCT02700295
- Acronym / sponsor ID
- OPHT-260514
- Conditions
- Myopia
- Keywords
- Orthokeratology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthokeratology contact lens group | – | Device: Orthokeratology lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 healthy volunteers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthokeratology lens | Device | Orthokeratology contact lens group |
Primary outcome
Quantitative changes in the corneal thickness
Time frame: 1 year
Qualitative changes in the corneal structure
Time frame: 1 year
2 secondary outcomes
Quantitative changes in the choroidal thickness
Time frame: 1 year
Qualitative changes in the choroidal structure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhöfer, Assoc. Prof. PD Dr (+43 1 4040029810, gerhard.garhoefer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative changes in the corneal thickness (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.