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

V

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)

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)
Experimental group
Treatment:
Device: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Lou-Ann Andersen

Data sourced from clinicaltrials.gov

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