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OpenTrials
Enrolling by Invitation

NCT Number: NCT06636019

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Augsburg

Augsburg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myopia control contact lens

Device

Myopia control contact lens is placed on the study eye.

Primary outcomes

  1. Choroidal thickness

    Time frame: 30 minutes

    Choroidal thickness is measured after contact lens wear.

Sponsors and collaborators

Lead sponsor

University Hospital Augsburg

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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