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

Vejle Hospital

Status

Active, not recruiting

Conditions

Myopia

Treatments

Device: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT06234189

TIDOCT

Details and patient eligibility

About

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).

Enrollment

16 patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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)