Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527274
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this study is to gain a better understanding of the retinal vascular changes that occur in response to the optical effect of a myopic defocus daily disposable soft contact lens MDSL in a group of healthy young myopic adults 18-35 years myopia -100D to -400D all genders It will also learn about the acceptance of this visual correction modality compared to regular contact lenses
The main questions to be answered are
To evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus after one week of MDSL wear
To evaluate changes in choroidal thickness at the macular level after one week of MDSL wear
To evaluate the visual comfort provided by this MDSL design using a questionnaire
Researchers will compare the MDSL to a daily disposable single vision soft lens SVSL used to correct myopia to determine if the addition of a defocus area makes a difference in the retinal response to the visual signal
Participants will be required to
Wear both MDSL and SVSL for one week each in a random order
Read letters to measure visual acuity
Have a deep scan of their retina with an optical coherence tomography OCT device
Rate the comfort and vision provided by both devices using a questionnaire
The main questions to be answered are
To evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus after one week of MDSL wear
To evaluate changes in choroidal thickness at the macular level after one week of MDSL wear
To evaluate the visual comfort provided by this MDSL design using a questionnaire
Researchers will compare the MDSL to a daily disposable single vision soft lens SVSL used to correct myopia to determine if the addition of a defocus area makes a difference in the retinal response to the visual signal
Participants will be required to
Wear both MDSL and SVSL for one week each in a random order
Read letters to measure visual acuity
Have a deep scan of their retina with an optical coherence tomography OCT device
Rate the comfort and vision provided by both devices using a questionnaire
Detailed Description:
Objective
The aim of this study is to gain a better understanding of the retinal vascular changes that occur in response to the optical effect of a myopic defocus daily disposable contact lens used in another ongoing research project NCT05191134
The primary objective of the study is to evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus following one weeks wear of a high peripheral add soft contact lens in a population of young myopic adults
The second objective is to assess changes in choroidal thickness at the macular level after one weeks wear of the high peripheral add soft contact lens
A third objective is to evaluate through questionnaire the visual comfort provided by this lens design
Materials and methods
25 myopic participants aged between 18 and 35 will be enrolled Each participant will be randomly fitted with two lenses a monofocal spherical soft lens nesofilcon A for one week and a high-add bifocal soft lens anti-myopia for the same duration of time Participants will be asked to attend three different visits one week apart
At visit 1 initial measurements of deep and superficial plexus blood vessel density and choroidal thickness will be taken with an angiographic optical coherence tomograph OCT-A Triton Topcon USA
These measurements will be repeated with other lenses at visit 2 and 3
The results will be compared Participants will be asked to evaluate the visual performance of each lens after 1 week of wear through a questionnaire
Hypothesis It is expected that one weeks wear of the peripheral myopic defocus contact lens will cause an increase in blood vessel density and a thickening of the choroid compared with initial measurements A decrease in blood vessel density and choroidal thinning is expected after one weeks wear of the spherical soft lens hyperopic defocus compared with baseline Both lenses will be well tolerated during daily activities
The aim of this study is to gain a better understanding of the retinal vascular changes that occur in response to the optical effect of a myopic defocus daily disposable contact lens used in another ongoing research project NCT05191134
The primary objective of the study is to evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus following one weeks wear of a high peripheral add soft contact lens in a population of young myopic adults
The second objective is to assess changes in choroidal thickness at the macular level after one weeks wear of the high peripheral add soft contact lens
A third objective is to evaluate through questionnaire the visual comfort provided by this lens design
Materials and methods
25 myopic participants aged between 18 and 35 will be enrolled Each participant will be randomly fitted with two lenses a monofocal spherical soft lens nesofilcon A for one week and a high-add bifocal soft lens anti-myopia for the same duration of time Participants will be asked to attend three different visits one week apart
At visit 1 initial measurements of deep and superficial plexus blood vessel density and choroidal thickness will be taken with an angiographic optical coherence tomograph OCT-A Triton Topcon USA
These measurements will be repeated with other lenses at visit 2 and 3
The results will be compared Participants will be asked to evaluate the visual performance of each lens after 1 week of wear through a questionnaire
Hypothesis It is expected that one weeks wear of the peripheral myopic defocus contact lens will cause an increase in blood vessel density and a thickening of the choroid compared with initial measurements A decrease in blood vessel density and choroidal thinning is expected after one weeks wear of the spherical soft lens hyperopic defocus compared with baseline Both lenses will be well tolerated during daily activities
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