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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcrySof single-piece IOL | Pseudophakic subjects previously implanted with an AcrySof single-piece IOL |
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| AcrySof multi-piece IOL | Pseudophakic subjects previously implanted with an AcrySof multi-piece IOL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof single-piece IOL | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean monocular best corrected distance visual acuity (BCDVA) | 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. | Up to 3 to 5 years post operative |
| Rate of protocol-specified ocular adverse events | 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:
| Up to 3 to 5 years post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Mean manifest refraction - Sphere | 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. | Up to 3-5 years postoperative |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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Subjects will be recruited from clinical sites in the United States and Canada.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velvet Clinical Research | Burbank | California | 91506 | United States | ||
| Levenson Eye Associates |
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| AcrySof multi-piece IOL | Device | 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. |
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| Mean manifest refraction - Cylinder |
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. |
| Up to 3-5 years postoperative |
| Mean manifest refraction - Axis | 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. | Up to 3-5 years postoperative |
| Manifest refraction spherical equivalent (MRSE) | 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. | Up to 3-5 years postoperative |
| Mean monocular uncorrected distance visual acuity (UCDVA) | 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. | Up to 3-5 years postoperative |
| Rate of additional adverse events - Ocular | 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. | Up to 3-5 years postoperative |
| Rate of device deficiencies | The subject's medical records will be reviewed for device deficiencies. Examples of device deficiencies include the following:
| Up to 3-5 years postoperative |
| Rate of posterior capsulotomies | 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. | Up to 3-5 years postoperative |
| Jacksonville |
| Florida |
| 32204 |
| United States |
| Virdi Eye Clinic | Rock Island | Illinois | 61201 | United States |
| SightMD | Babylon | New York | 11702 | United States |
| Texan Eye | Austin | Texas | 78731 | United States |
| Chu Eye Institute | Fort Worth | Texas | 76107 | United States |
| Centro Oftalmologico Metropolitano | San Juan | 00921 | Puerto Rico |
| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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