A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AcrySof single-piece IOL Pseudophakic subjects previously implanted with an AcrySof single-piece IOL |
Device: AcrySof single-piece IOL
Acrylic single-piece intraocular lens placed in the capsular bag in the posterior chamber of the eye during cataract surgery as a replacement for the natural crystalline lens.
Other Names:
|
| AcrySof multi-piece IOL Pseudophakic subjects previously implanted with an AcrySof multi-piece IOL |
Device: AcrySof multi-piece IOL
Acrylic multi-piece intraocular lens placed in the capsular bag in the posterior chamber of the eye during cataract surgery as a replacement for the natural crystalline lens.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean monocular best corrected distance visual acuity (BCDVA) [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 [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 Outcome Measures
- Mean manifest refraction - Sphere [Up to 3-5 years postoperative]
Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. The spherical component will be measured in diopters.
- Mean manifest refraction - Cylinder [Up to 3-5 years postoperative]
Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. The cylindrical component will be measured in diopters.
- Mean manifest refraction - Axis [Up to 3-5 years postoperative]
Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. The axial component will be measured in degrees.
- Manifest refraction spherical equivalent (MRSE) [Up to 3-5 years postoperative]
Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. MRSE will be calculated as [Sphere minus (cylinder divided by 2)] and reported in diopters.
- Mean monocular uncorrected distance visual acuity (UCDVA) [Up to 3-5 years postoperative]
Visual acuity will be assessed for each eye individually with no correction in place using letter charts placed at a distance of 6 meters (or 4 meters adjusted for infinity) from the subject. UCDVA will be measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
- Rate of additional adverse events - Ocular [Up to 3-5 years postoperative]
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. This outcome measure will include all ocular adverse events other than the protocol-specified adverse events.
- Rate of device deficiencies [Up to 3-5 years postoperative]
The subject's medical records will be reviewed for device deficiencies. Examples of device deficiencies include the following: Failure to meet product specifications (e.g., incorrect IOL power); IOL defect; Broken IOL optic; Broken IOL haptic; Scratched IOL optic; Unsealed device packaging; Suspected product contamination; Lack of performance. A device deficiency may or may not be associated with subject harm.
- Rate of posterior capsulotomies [Up to 3-5 years postoperative]
Posterior capsulotomy is surgery performed on the back side of the capsular bag in the eye. A laser is used to make an opening in the cloudy capsule to allow light to pass through again for clear vision. The subject's medical records will be reviewed for the occurrence of posterior capsulotomy.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Subject is implanted with one of the study IOL models between 3 and 5 years previously.
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Subject follow-up is expected to be possible during the duration of the study.
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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.
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Documented medical history and required pre-operative baseline information is available for retrospective data collection.
Key Exclusion Criteria:
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Subject is participating in a separate investigational drug or device study.
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Pregnancy at the time of enrollment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Lead, Surgical, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ILB609-N001