Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636019
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Change in Choroidal Thickness of Myopic Eyes with a Myopia Control Contact Lens
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Change in Choroidal Thickness of Myopic Eyes with a Myopia Control Contact Lens
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 -05 diopters in the spherical equivalent will be included with laterality rightleft 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
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 -05 diopters in the spherical equivalent will be included with laterality rightleft 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None