Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-26 @ 9:25 AM
Study NCT ID:
NCT06553404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myoslow Lens Study to Control Myopia in Children
Sponsor:
Crystal Optic
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Controlled Double Masked Trial to Assess the Performance of Myoslow Lens in Slowing Myopia Progression in Children
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Prospective, randomized, controlled double masked trial to assess the performance of Myoslow lens in slowing myopia progression in children.
The following study measures will be assessed:
* Demographics and medical history
* Current spectacles
* Best Corrected Visual Acuity (BCVA) assessed by Measurement and Summation (M\&S) system
* Biometry
* Cover test
* Stereopsis
* Ocular Motility
* Pupil responses
* Cycloplegic refraction
* Fundus Examination
* Vision related quality of life using the questionnaire Pediatric Refractive Error Profile (PREP)2
* Adverse Events
The following study measures will be assessed:
* Demographics and medical history
* Current spectacles
* Best Corrected Visual Acuity (BCVA) assessed by Measurement and Summation (M\&S) system
* Biometry
* Cover test
* Stereopsis
* Ocular Motility
* Pupil responses
* Cycloplegic refraction
* Fundus Examination
* Vision related quality of life using the questionnaire Pediatric Refractive Error Profile (PREP)2
* Adverse Events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: