Clinical Trial: A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: OBSERVATIONAL

Official Title: A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses

Brief Summary: The purpose of this post-market clinical follow-up (PMCF) study is to describe the long-term safety and performance of AcrySof Single-Piece and AcrySof Multi-Piece monofocal intraocular lenses (IOLs).

Detailed Summary: The study includes a retrospective chart review for pre-operative, operative, and post-operative data collection, and a prospective, standard-of-care visit to collect study endpoints.
Sponsor: Alcon Research

Current Primary Outcome: Retrospectively, the subject's medical records will be reviewed for assessments of BCDVA.
Prospectively, visual acuity will be assessed for each eye individually with correction in place using letter charts placed at a distance of 6 meters (or 4 meters adjusted for infinity) from the subject.
BCDVA will be reported in logarithm minimum angle of resolution (logMAR), where a logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight) and lower logMAR values indicate better visual acuity.

Original Primary Outcome: Retrospectively, the subject's medical records will be reviewed for assessments of BCDVA.
Prospectively, visual acuity will be assessed for each eye individually with correction in place using letter charts placed at a distance of 6 meters (or 4 meters adjusted for infinity) from the subject.
BCDVA will be reported in logarithm minimum angle of resolution (logMAR), where a logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight) and lower logMAR values indicate better visual acuity.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Alcon Research

Dates:
Date Received: March 23, 2023
Date Started: August 28, 2023
Date Completion: August 28, 2023
Last Updated: November 14, 2023
Last Verified: September 01, 2023