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OpenTrials
Completed

NCT Number: NCT06234189

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

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).

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ophthalmic department, Vejle Hospital

Vejle, Southern Denmark, 7100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myopic children using Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) from the ongoing randomized clinical non-inferiority study: "Defocus Incorporated Multiple Segment (DIMS) Spectacle Lenses versus Orthokeratology lenses (OKL) for slowing myopia progression in children aged 6-12 years. A non-inferiority randomized clinical trial. The NISDO study" (ClinicalTrials.gov Identifier NCT05134935).
  • 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

  • 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).
  • Previous myopia control treatment.

Treatment and study plan

Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

Device

30 minutes without DIMS and 30 minutes with DIMS

Primary outcomes

  1. Choroidal thickness

    Time frame: During 60 minutes

    Thickness is measured in um

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study 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.

Acronym: TIDOCT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2024
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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