NCT06234189

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2024

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

January 22, 2024

Last Update Submit

June 18, 2025

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Choroidal thickness

    Thickness is measured in um

    During 60 minutes

Study Arms (1)

Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

EXPERIMENTAL
Device: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

Interventions

Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)DEVICE

30 minutes without DIMS and 30 minutes with DIMS

Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ophthalmic department, Vejle Hospital

Vejle, Southern Denmark, 7100, Denmark

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Lou-Ann Andersen

    Vejle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start

February 1, 2024

Primary Completion

March 7, 2024

Study Completion

March 7, 2024

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)