Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:15 AM
Study NCT ID:
NCT05250206
Status:
COMPLETED
Last Update Posted:
2025-06-10
First Post:
2022-02-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes
Sponsor:
Indizen Optical Technologies, S.L.U.
Organization:
Study Overview
Official Title:
Evaluation of Ophthalmic Lenses for Myopia Management
Status:
COMPLETED
Status Verified Date:
2025-02
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:
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.
Detailed Description:
A prospective, double-blind, randomized clinical trial (RCT) to analyze the effect of a new ophthalmic lens prototype on myopia progression. The follow-up period to evaluate the efficacy of the lens will be 3 years including a total of 5 visits.
The sample will consist of a group of 92 myopic children who will be randomly assigned to one of the treatment groups:
* Control group who will receive standard monofocal lenses.
* Treatment group who will wear a prototype lens based on peripheral positive defocus.
The sample will consist of a group of 92 myopic children who will be randomly assigned to one of the treatment groups:
* Control group who will receive standard monofocal lenses.
* Treatment group who will wear a prototype lens based on peripheral positive defocus.
Study Oversight
Has Oversight DMC:
True
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?: