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

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.

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).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Southern Denmark
    • Vejle, Southern Denmark, Denmark, 7100
      • The Ophthalmic department, Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)	Device: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS); 30 minutes without DIMS and 30 minutes with DIMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choroidal thickness	Thickness is measured in um	During 60 minutes

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Principal Investigator: Lou-Ann Andersen, Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): March 7, 2024
• Study Completion (Actual): March 7, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: TIDOCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No