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

NCT06647472 | Active Not Recruiting

• 1 other identifier: The ProMOC study
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Healthy; Orthokeratology

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vejle Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Øjenafdelingen, Vejle Sygehus

Vejle, Denmark

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)