OrthokeratologyNCT00816569
Orthokeratology for Keratoconus
A study testing Orthokeratology contact lenses in people with Orthokeratology and Keratoconus, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
To investigate a possible benefit of Orthokeratology contact lenses to improve uncorrected visual acuity of keratoconus patients Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Orthokeratology, Keratoconus
- What is being tested?
- Orthokeratology contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to Aug 2009
- Phase
- Interventional
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Moderate Keratoconus
- No apical scars
Who cannot join
- Advanced Keratoconus
- Apical scaring
- Contact lens intolerance
Trial locations and contacts
1 site in 1 country.
Israel1 site
: Hadassah Medical Organization,
Jerusalem, 91120
: Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Orthokeratology Contact Lenses for Keratoconus
To investigate a possible benefit of Orthokeratology contact lenses to improve uncorrected visual acuity of keratoconus patients
- Conditions
- Orthokeratology, Keratoconus
- Being tested
- Orthokeratology contact lenses
- Keywords
- Orthokeratology, Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthokeratology contact lensesDevice
Wearing Orthokeratology lens in one eye of a keratoconus patient
| Study group | Role | What they receive |
|---|---|---|
| Keratoconus | Experimental | One eye of Keratoconus patient Receives: Device: Orthokeratology contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Visual acuity
Measured: After 1 month
Secondary outcomes (1)
Amount of change in corneal video-topography
Measured: At one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthokeratologyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816569
- Sponsor's protocol ID
- dvleyes-HMO-CTIL
- Status last verified
- Dec 2008
- First submitted
- 31 Dec 2008
- Last updated
- 1 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthokeratology Contact Lenses for Keratoconus
- ClinicalTrials.gov ID
- NCT00816569
- Acronym / sponsor ID
- dvleyes-HMO-CTIL
- Conditions
- Orthokeratology, Keratoconus
- Keywords
- Orthokeratology, Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 1 Jan 2009 (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.
To investigate a possible benefit of Orthokeratology contact lenses to improve uncorrected visual acuity of keratoconus patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keratoconus | Experimental | Device: Orthokeratology contact lensesOne eye of Keratoconus patient |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Moderate Keratoconus
- No apical scars
Key exclusion criteria (3 listed)
- Advanced Keratoconus
- Apical scaring
- Contact lens intolerance
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 contact lensesWearing Orthokeratology lens in one eye of a keratoconus patient | Device | Keratoconus |
Primary outcome
Uncorrected Visual acuity
Time frame: After 1 month
1 secondary outcome
Amount of change in corneal video-topography
Time frame: At one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2009.
Related trials for Orthokeratology
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Not yet recruiting
SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
High Myopia
Active, not recruiting
Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control
Myopia
Active, not recruitingObservational study
Proteomic Analysis on Myopic Children Using Orthokeratology Lenses With Good or Poor Myopic Control
Myopia, Healthy
Not yet recruitingObservational study
Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens Wear
Progressive Myopia, Pediatric Myopia
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?
A study testing Orthokeratology contact lenses in people with Orthokeratology and Keratoconus, run by Hadassah Medical Organization at 1 site in Israel.
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 2 inclusion and 3 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 1 Jan 2009. 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 Israel. 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 David Landau, MD (00 972 54 4807077, dvl_eyes@slimail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Visual acuity (time frame: After 1 month). 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 1 Jan 2009.