An observational study in Aphakia, sponsored by Alcon Research. Completed at 7 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Alcon Research (part of Alcon) · Observational
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 138 is above the median of 95 across 15 observational studies indexed under Aphakia.
Browse Aphakia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited from clinical sites in the United States and Canada.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pseudophakic subjects previously implanted with an AcrySof single-piece IOL
Device: AcrySof single-piece IOL
Pseudophakic subjects previously implanted with an AcrySof multi-piece IOL
Device: AcrySof multi-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.
Also known as: Models SN60WF, ACU0T0, SN6AT2, SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, SN6AT9, SA6AT2, SA6AT3, SA6AT4, SA6AT5, SA6AT6, SA6AT7, SA6AT8, SA6AT9
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.
Also known as: Models MN50BM, MA60AC, MA60MA
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2023 to primary completion in Jun 2025, 21 months.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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