Proteomic Analysis on Myopic Children Using Orthokeratolo... | NCT06647472

Studies
Proteomic Analysis on Myopic Children Using Orthokeratology Lenses With Good or Poor Myopic Control

NCT06647472

Sponsor

Vejle Hospital

Status

Active, not recruiting

Last Update Posted

Mar 10, 2026Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Myopia
Healthy
Orthokeratology

Interventions

Not provided

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

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2024Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Oct 15, 2024

First Submission Date that Met QC Criteria

Oct 15, 2024

First Posted Date

Oct 17, 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

Mar 9, 2026

Last Update Posted Date

Mar 10, 2026Actual

Name	Class
University of Aarhus	OTHER

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

Description Module

Brief Summary

The key objective of the study is to gain an understanding of the biochemical processes that contribute to orthokeratology lenses being more effective in specific individuals compared to others. With this knowledge, we hope to optimize treatment effectiveness in those currently experiencing less favorable outcomes from treatment in the future.

The primary aim is to investigate differences in protein levels in children using orthokeratology lenses with various effects of myopia control.

Hypothesis: There is a significant difference in the expression of molecules in children with various effects of myopia control.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in protein levels measured by mass spectrometry label-free quantification (LFQ) between children using orthokeratology lenses with different levels of myopia control effectiveness		At baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children treated with orthokeratology lenses.
Children on or above the 95th percentile of myopia growth curves for European children at the time of treatment initiation.
Treatment and follow-up duration ≥ 6 months.

Exclusion Criteria:

Current use of eye drops.
Objective signs of dry eyes on slit-lamp examination.
Active eye infection.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Children who are currently being treated with orthokeratology lenses at the Ophthalmic Department, Vejle Hospital, University Hospital of Southern Denmark.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Øjenafdelingen, Vejle Sygehus		Vejle			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