Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 5:52 PM
Study NCT ID:
NCT04936256
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens
Sponsor:
Gainesville Eye Associates
Organization:
Study Overview
Official Title:
Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens
Status:
COMPLETED
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:
The objective is to evaluate refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months).
Detailed Description:
This study is a single-arm, evaluator masked clinical evaluation study of refractive stability, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and defocus curve.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: