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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

• Registration Number: NCT06234189
• Lead Sponsor: Vejle Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Study Start: 2024-02-01
• Primary Completion: 2024-03-07
• Study Completion: 2024-03-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)	Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)	-

Primary Outcome Measures

Name	Time	Method
Choroidal thickness	During 60 minutes	Thickness is measured in um

Trial Locations

Locations (1)

The Ophthalmic department, Vejle Hospital; 🇩🇰 Vejle, Southern Denmark, Denmark