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.
Study Type
OBSERVATIONAL
Enrollment
138
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.
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.
Velvet Clinical Research
Burbank, California, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Virdi Eye Clinic
Rock Island, Illinois, United States
SightMD
Babylon, New York, United States
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.
Time frame: 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: * Cystoid macular edema (CME) * Hypopyon * Endophthalmitis * Lens dislocation * Pupillary block * Retinal detachment * Secondary surgical interventions
Time frame: Up to 3 to 5 years post operative
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.
Time frame: Up to 3-5 years postoperative
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.
Time frame: Up to 3-5 years postoperative
Mean manifest refraction - Axis
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Texan Eye
Austin, Texas, United States
Chu Eye Institute
Fort Worth, Texas, United States
Centro Oftalmologico Metropolitano
San Juan, Puerto Rico
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: * 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.
Time frame: 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.
Time frame: Up to 3-5 years postoperative