Viewing Study NCT06650358


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Ignite Modification Date: 2025-12-25 @ 12:05 AM
Study NCT ID: NCT06650358
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-10-21
First Post: 2024-10-18
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Clinical Outcomes of Patients with LAL+ in At Least One Eye
Sponsor: Frank A. Bucci, Jr., M.D.
Organization:

Study Overview

Official Title: CLINICAL OUTCOMES of BILATERAL PSEUDOPHAKIC PATIENTS with a LIGHT ADJUSTABLE LENS+ (LAL)+ IMPLANTED in AT LEAST ONE EYE
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-10
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 of this study is to collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens+ (LAL+) in at least one eye
Detailed Description: A retrospective-prospective, single-center study will be conducted. Patient charts will be retrospectively reviewed to collect data from the patient's comprehensive preoperative exam. Subjects will attend one stud visit post final LDD light treatment.

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?: True
Is an FDA AA801 Violation?: