NCT06636019

Brief Summary

In this study, the direct effect of the MiSight contact lens (Cooper Vision), a daily disposable contact lens recently approved in Germany for the treatment of myopia, will be investigated. The aim of this study is to demonstrate an increase in choroidal thickness due to the myopic defocus induced by the contact lens. The increase in choroidal thickness after 30 minutes of exposure to the myopic defocus induced by the contact lens will be demonstrated by measuring the subfoveal and macular choroidal thickness.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

August 13, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

October 8, 2024

Last Update Submit

March 25, 2025

Conditions

Myopia

Keywords

MyopiaContact LensMyopia progression

Outcome Measures

Primary Outcomes (1)

  • Choroidal thickness

    Choroidal thickness is measured after contact lens wear.

    30 minutes

Study Arms (1)

Interventional arm

EXPERIMENTAL

The myopia control contact lens will be administered in this group.

Device: Myopia control contact lens

Interventions

Myopia control contact lensDEVICE

Myopia control contact lens is placed on the study eye.

Interventional arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • myopic refraction
  • consent to participate
  • minimum age 18 years
  • full legal capacity

You may not qualify if:

  • ocular disease affecting imaging quality including but not limited to cataract, keratoconus
  • ocular disease affecting choroidal thickness (pachychoroidal disease)
  • astigmatism greater than 1,5 diopters
  • best corrected distance visual acuity of 0,1 logMAR or worse
  • status post eye surgery
  • status post treatment for myopia control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Augsburg

Augsburg, Germany

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 10, 2024

Study Start

August 13, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)