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NCT06234189 Clinical Trial

The Immediate Effect of Defocus Spectacles On the Choroid Thickness Using Optical Coherence Tomography on Children

Myopia Clinical Trial

— TIDOCT  

Official title:
The Immediate Effect of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) on the Choroid Thickness Using Swept Source-Optical Coherence Tomography (SS-OCT) on Children.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06234189
Other study ID # TIDOCT
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date June 2024

Study information
Verified date May 2024
Source Vejle Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose is to examine temporary changes in the subfoveal choroid thickness after removal and after resumed use of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 16
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years and older
Eligibility Inclusion Criteria: - Myopic children using Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) from the ongoing randomized clinical non-inferiority study: "Defocus Spectacle Lenses (DIMS) versus Orthokeratology lenses (OKL) for slowing myopia progression in children" (ClinicalTrials.gov Identifier NCT05134935) - Myopia at the time of inclusion in the NISDO study: -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes) - Anisometropia < 1,5 D cycloplegic spherical equivalent refractive error - Best corrected visual acuity (inclusive): 1.0 Snellen (equivalent to = 3/5 letter on the 1.0 line = 83 ETDRS letters) Exclusion Criteria: - Manifest or intermittent squint - 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)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)
30 minutes without DIMS and 30 minutes with DIMS

Locations
Country Name City State
Denmark The Ophthalmic department, Vejle Hospital Vejle Southern Denmark

Sponsors (1)
Lead Sponsor Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Choroidal thickness Thickness is measured in um During 60 minutes
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