Status:
COMPLETED
Clinical Study Of Nearsightedness; TReatment With Orthokeratology Lenses (CONTROL)
Lead Sponsor:
Vejle Hospital
Collaborating Sponsors:
Ens Eyes
Conditions:
Myopia
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
Myopia is a common disease of the eye with increasing prevalence in the Western World as well as in South East Asia where 60-90% of the children are affected. High myopia is associated with an increas...
Detailed Description
Myopia is a common disease of the eye with increasing prevalence in the Western World as well as in South East Asia where 60-90% of the children are affected. A Danish study found that early debut of ...
Eligibility Criteria
Inclusion
- Myopia -0.5 to -4.75 dioptries spherical in one or both eyes.
- Regular astigmatism ≤ -2.5 diopters in one or both eyes.
- Age 6 ≥ 12 years.
- Anisometropia \< 1.5 D spherical equivalent.
- Best corrected visual acuity of 0.1 logMAR or better in both eyes.
- Acceptance of treatment randomization.
Exclusion
- Manifest or latent squint.
- Contraindications to the use of OKL comprising keratoconus, allergic conjunctivitis and keratoconjunctivitis sicca.
- Previous eye surgery.
- Chronic eye disease demanding daily use of eye drops.
- Non-compliance to eye examinations (unstable fixation or intolerance to OKL).
- One or both parents being ethnical Asian, African, Hispanic or Spanish.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03246464
Start Date
March 1 2017
End Date
April 17 2020
Last Update
May 28 2020
Active Locations (1)
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1
Vejle Hospital
Vejle, Jylland, Denmark, 7100