A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aphakia
- Sponsor
- Alcon Research
- Enrollment
- 138
- Locations
- 7
- Primary Endpoint
- Mean monocular best corrected distance visual acuity (BCDVA)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is implanted with one of the study IOL models between 3 and 5 years previously.
- •Subject follow-up is expected to be possible during the duration of the study.
- •Subject or legally authorized representative must be able to understand and sign the IRB/EC approved Informed Consent form. Minor subjects will complete an Assent Form.
- •Documented medical history and required pre-operative baseline information is available for retrospective data collection.
Exclusion Criteria
- •Subject is participating in a separate investigational drug or device study.
- •Pregnancy at the time of enrollment.
Outcomes
Primary Outcomes
Mean monocular best corrected distance visual acuity (BCDVA)
Time Frame: Up to 3 to 5 years post operative
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.
Rate of protocol-specified ocular adverse events
Time Frame: Up to 3 to 5 years post operative
The subject's medical records will be reviewed for medical conditions. Medical conditions that started after initial exposure to the study model IOLs will be captured as adverse events. The following adverse events are pre-specified for this outcome measure: * Cystoid macular edema (CME) * Hypopyon * Endophthalmitis * Lens dislocation * Pupillary block * Retinal detachment * Secondary surgical interventions
Secondary Outcomes
- Rate of additional adverse events - Ocular(Up to 3-5 years postoperative)
- Mean manifest refraction - Axis(Up to 3-5 years postoperative)
- Mean manifest refraction - Cylinder(Up to 3-5 years postoperative)
- Mean monocular uncorrected distance visual acuity (UCDVA)(Up to 3-5 years postoperative)
- Manifest refraction spherical equivalent (MRSE)(Up to 3-5 years postoperative)
- Rate of posterior capsulotomies(Up to 3-5 years postoperative)
- Mean manifest refraction - Sphere(Up to 3-5 years postoperative)
- Rate of device deficiencies(Up to 3-5 years postoperative)