The Immediate Effect of Defocus Spectacles On the Choroid Thickness Using Optical Coherence Tomography on Children
NCT ID: NCT06234189
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2024-02-01
2024-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)
Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)
30 minutes without DIMS and 30 minutes with DIMS
Interventions
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Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)
30 minutes without DIMS and 30 minutes with DIMS
Eligibility Criteria
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Inclusion Criteria
* Myopia at the time of inclusion in the NISDO study (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
* Anisometropia at the time of inclusion in the NISDO study ≤ 1.50 D cycloplegic spherical equivalent refractive error.
* Best corrected visual acuity (inclusive) at the time of inclusion in the NISDO study: 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters).
Exclusion Criteria
* Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic 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 anxiety towards contact lenses).
* Previous myopia control treatment.
10 Years
ALL
No
Sponsors
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Vejle Hospital
OTHER
Responsible Party
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Principal Investigators
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Lou-Ann Andersen
Role: PRINCIPAL_INVESTIGATOR
Vejle Hospital
Locations
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The Ophthalmic department, Vejle Hospital
Vejle, Southern Denmark, Denmark
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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TIDOCT
Identifier Type: -
Identifier Source: org_study_id
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