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Enrolling by invitation NCT06636019

Change in Choroidal Thickness of Myopic Eyes With a Myopia Control Contact Lens

No phase Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Myopia control contact lens.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

The increasing incidence of short-sightedness (myopia) worldwide has led to the development of various therapies to control axial length myopia. The latest developments include contact lenses to inhibit the growth of the bulb length, which should influence the growth of the eye in childhood and adolescence by inducing a myopic defocus in the periphery of the retina.

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. In addition, the influence of accommodation will be investigated by measuring the choroidal thickness after 30 minutes of activity at near and far distance. One eye of each of 8 healthy subjects with myopic refraction from -0.5 diopters in the spherical equivalent will be included, with laterality (right/left) being randomized. The choroidal thickness is measured using optical coherence tomography (OCT), which is standard in clinical routine. The examination is non-invasive and is carried out at three points in time: The baseline measurement is carried out before inserting the contact lens, then after 30 minutes of exposure and near focusing. A further measurement is carried out within a week after a further 30 minutes of exposure and distance focusing, so that the results are not distorted by the previous near work. In addition, the axial length is determined at each of the 3 measurement times using optical biometry.

Interventions

  • Device Myopia control contact lens
    Myopia control contact lens is placed on the study eye.

Primary outcome measures

  • Choroidal thickness [Time frame: 30 minutes]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Germany · 1 center
  • University Hospital Augsburg — Augsburg

Identifiers

NCT: NCT06636019 · 24-0398

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗