The Immediate Effect of Defocus Spectacles On the Choroid... | NCT06234189

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

NCT06234189

Sponsor

Vejle Hospital

Status

Completed

Last Update Posted

Jun 25, 2025Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Myopia

Interventions

Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Mar 7, 2024Actual

Completion Date

Mar 7, 2024Actual

First Submitted Date

Jan 22, 2024

First Submission Date that Met QC Criteria

Jan 22, 2024

First Posted Date

Jan 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2025

Last Update Posted Date

Jun 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)	Experimental		Device: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)	Device	30 minutes without DIMS and 30 minutes with DIMS	Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Lou-Ann Andersen	Vejle Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Ophthalmic department, Vejle Hospital		Vejle	Southern Denmark	7100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases