A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
- Conditions
- Aphakia
- Interventions
- Device: AcrySof single-piece IOLDevice: AcrySof multi-piece IOL
- Registration Number
- NCT05799950
- Lead Sponsor
- Alcon Research
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 230
- 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.
Key
- Subject is participating in a separate investigational drug or device study.
- Pregnancy at the time of enrollment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AcrySof single-piece IOL AcrySof single-piece IOL Pseudophakic subjects previously implanted with an AcrySof single-piece IOL AcrySof multi-piece IOL AcrySof multi-piece IOL Pseudophakic subjects previously implanted with an AcrySof multi-piece IOL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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 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.
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.
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.
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.
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.
Trial Locations
- Locations (7)
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
SightMD
🇺🇸Babylon, New York, United States
Virdi Eye Clinic
🇺🇸Rock Island, Illinois, United States
Texan Eye
🇺🇸Austin, Texas, United States
Centro Oftalmologico Metropolitano
🇵🇷San Juan, Puerto Rico
Chu Eye Institute
🇺🇸Fort Worth, Texas, United States
Velvet Clinical Research
🇺🇸Burbank, California, United States