AphakiaNCT05799950
A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
An observational study of Aphakia, run by Alcon Research at 7 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aphakia
- What is being tested?
- AcrySof single-piece IOL and AcrySof multi-piece IOL
- Type of treatment
- Medical device
- How many people
- 138 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 28 Aug 2023to 2 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Subjects will be recruited from clinical sites in the United States and Canada.
Who may be able to join
- 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.
Who cannot join
- Subject is participating in a separate investigational drug or device study.
- Pregnancy at the time of enrollment.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Texan Eye
Austin, Texas, 78731
SightMD
Babylon, New York, 11702
Velvet Clinical Research
Burbank, California, 91506
Chu Eye Institute
Fort Worth, Texas, 76107
Levenson Eye Associates
Jacksonville, Florida, 32204
Virdi Eye Clinic
Rock Island, Illinois, 61201
About this study
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).
Read the 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.
- Conditions
- Aphakia
- Being tested
- AcrySof single-piece IOL, AcrySof multi-piece IOL
- Keywords
- Intraocular lens, Cataract
- Medical subject headings
- Aphakia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof single-piece IOLDevice
Also called Models SN60WF, ACU0T0, SN6AT2, SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, SN6AT9, SA6AT2, SA6AT3, SA6AT4, SA6AT5, SA6AT6, SA6AT7, SA6AT8, SA6AT9
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.
AcrySof multi-piece IOLDevice
Also called Models MN50BM, MA60AC, MA60MA
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.
| Study group | Role | What they receive |
|---|---|---|
| AcrySof single-piece IOL | Pseudophakic subjects previously implanted with an AcrySof single-piece IOL Receives: Device: AcrySof single-piece IOL | |
| AcrySof multi-piece IOL | Pseudophakic subjects previously implanted with an AcrySof multi-piece IOL Receives: Device: AcrySof multi-piece IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 3 to 5 years post operative
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3-5 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start28 Aug 2023
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799950
- Sponsor's protocol ID
- ILB609-N001
- Status last verified
- Aug 2025
- First submitted
- 23 Mar 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
- ClinicalTrials.gov ID
- NCT05799950
- Acronym / sponsor ID
- ILB609-N001
- Conditions
- Aphakia
- Keywords
- Intraocular lens, Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AcrySof single-piece IOL | – | Device: AcrySof single-piece IOLPseudophakic subjects previously implanted with an AcrySof single-piece IOL |
| AcrySof multi-piece IOL | – | Device: AcrySof multi-piece IOLPseudophakic subjects previously implanted with an AcrySof multi-piece IOL |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from clinical sites in the United States and Canada.
Key inclusion criteria (4 listed)
- 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 exclusion criteria (2 listed)
- Subject is participating in a separate investigational drug or device study.
- Pregnancy at the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcrySof single-piece IOLAlso: Models SN60WF, ACU0T0, SN6AT2, SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, SN6AT9, SA6AT2, SA6AT3, SA6AT4, SA6AT5, SA6AT6, SA6AT7, SA6AT8, SA6AT9Acrylic 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. | Device | AcrySof single-piece IOL |
| AcrySof multi-piece IOLAlso: Models MN50BM, MA60AC, MA60MAAcrylic 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. | Device | AcrySof multi-piece IOL |
Primary outcome
Mean monocular best corrected distance visual acuity (BCDVA)
Time frame: 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
Time frame: 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
8 secondary outcomes
Mean manifest refraction - Sphere
Time frame: Up to 3-5 years postoperative
Mean manifest refraction - Cylinder
Time frame: Up to 3-5 years postoperative
Mean manifest refraction - Axis
Time frame: Up to 3-5 years postoperative
Manifest refraction spherical equivalent (MRSE)
Time frame: Up to 3-5 years postoperative
Mean monocular uncorrected distance visual acuity (UCDVA)
Time frame: Up to 3-5 years postoperative
Rate of additional adverse events - Ocular
Time frame: Up to 3-5 years postoperative
Rate of device deficiencies
Time frame: Up to 3-5 years postoperative
Rate of posterior capsulotomies
Time frame: Up to 3-5 years postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Lead, Surgical study director
Alcon Research, LLC
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphakia, run by Alcon Research at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean monocular best corrected distance visual acuity (BCDVA) (time frame: Up to 3 to 5 years post operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.