CataractNCT06060041
IC-8 Apthera IOL New Enrollment Post Approval Study
An observational study of Cataract and Presbyopia, run by Bausch & Lomb Incorporated at 14 sites in United States.
Trial summary
The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract, Presbyopia, Posterior Capsule Opacification
- How many people
- 435 participants
- Where
- 14 sitesUnited States
- Study dates
- 8 Sep 2023to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- Adult, Older adult
Study population: Potential study subjects will be recruited from patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification in the IC-8 Apthera IOL eye which requires treatment with Nd:YAG laser capsulotomy
Who may be able to join
- 22 years of age or older, any race and any gender;
- Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye
- Able to comprehend and have signed a statement of informed consent;
- Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
- Clear intraocular media in both eyes;
- Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation;
- Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL.
Who cannot join
- Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye;
- Irregular astigmatism in either eye;
- History of retinal disease;
- Active or recurrent anterior segment pathology;
- Presence of ocular abnormalities;
- Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment;
Show all 12Show fewer
- Previous corneal or intraocular surgery, except cataract surgery;
- History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
- Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study;
- Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye;
- Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study.
- Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Ophthalmic Partners, PC
Bala-Cynwyd, Pennsylvania, 19004
- Recruiting
Oakland Eye
Birmingham, Michigan, 48009
- Recruiting
Utah Eye Centers
Bountiful, Utah, 84010
- Recruiting
Argus Research Center
Cape Coral, Florida, 33909
- Recruiting
Trinity Research Group, LLC
Dothan, Alabama, 36301
- Recruiting
Eye Associates of New Jersey
Dover, New Jersey, 07801
- Recruiting
Price Vision Group
Indianapolis, Indiana, 46260
- Recruiting
Feinerman Vision Center
Newport Beach, California, 92663
OD
- Recruiting
Vance Thompson Vision - Omaha
Omaha, Nebraska, 68137
- Recruiting
Virdi Eye Clinic and Laser Vision Center
Rock Island, Illinois, 61201
- Recruiting
Northern New Jersey Eye Institute
South Orange, New Jersey, 07079
- Recruiting
Berkeley Eye Center
Sugar Land, Texas, 77478
- Recruiting
Stephenson Eye Associates
Venice, Florida, 34285
- Recruiting
Grene Vision Group
Wichita, Kansas, 67206
About this study
The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.
Read the detailed description
Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.
- Conditions
- Cataract, Presbyopia, Posterior Capsule Opacification
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IC-8 Apthera intraocular lens (IOL) Group | Patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment
Rates of additional Nd:YAG laser treatments in the eye implanted with the IC-8 Apthera intraocular lens (IOL) beyond the initial Nd:YAG laser treatment will be assessed through 24 months post IC-8 Apthera IOL implantation
Measured: 24 Months post IC-8 Apthera IOL Implantation
Nd:YAG laser treatment outcome and/or complications
Nd:YAG laser treatment outcomes and/or complications in the eye implanted with the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation.
Measured: 24 Months post IC-8 Apthera IOL Implantation
IOL related assessments
The appearance of the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation
Measured: 24 Months post IC-8 Apthera IOL implantation
Rates of Secondary Surgical Interventions (SSIs)
Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be assessed through 24 months post IC-8 Apthera IOL implantation
Measured: 24 Months post IC-8 Apthera IOL implantation
Rates of other serious adverse events
Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation
Measured: 24 Months post IC-8 Apthera IOL implantation
Rates of ocular adverse events
Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation
Measured: 24 Months post IC-8 Apthera IOL implantation
Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire
Subjective responses to the QoV Questionnaire that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.
Measured: 24 Months post IC-8 Apthera IOL implantation
Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ)
Subjective responses to the Small Aperture Patient Questionnaire (SAPQ) that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.
Measured: 24 Months post IC-8 Apthera IOL implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start8 Sep 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 435 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060041
- Sponsor's protocol ID
- SAIL-101-PAS2
- Status last verified
- Jan 2026
- First submitted
- 19 Sep 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IC-8 Apthera IOL New Enrollment Post Approval Study
- ClinicalTrials.gov ID
- NCT06060041
- Acronym / sponsor ID
- SAIL-101-PAS2
- Conditions
- Cataract, Presbyopia, Posterior Capsule Opacification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 435 participants (estimated)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 29 Sep 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 study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.
Detailed description
Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IC-8 Apthera intraocular lens (IOL) Group | – | –Patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Potential study subjects will be recruited from patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification in the IC-8 Apthera IOL eye which requires treatment with Nd:YAG laser capsulotomy
Key inclusion criteria (7 listed)
- 22 years of age or older, any race and any gender;
- Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye
- Able to comprehend and have signed a statement of informed consent;
- Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
- Clear intraocular media in both eyes;
Key exclusion criteria (12 listed)
- Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye;
- Irregular astigmatism in either eye;
- History of retinal disease;
- Active or recurrent anterior segment pathology;
- Presence of ocular abnormalities;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment
Time frame: 24 Months post IC-8 Apthera IOL Implantation
Rates of additional Nd:YAG laser treatments in the eye implanted with the IC-8 Apthera intraocular lens (IOL) beyond the initial Nd:YAG laser treatment will be assessed through 24 months post IC-8 Apthera IOL implantation
Nd:YAG laser treatment outcome and/or complications
Time frame: 24 Months post IC-8 Apthera IOL Implantation
Nd:YAG laser treatment outcomes and/or complications in the eye implanted with the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation.
IOL related assessments
Time frame: 24 Months post IC-8 Apthera IOL implantation
The appearance of the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation
Rates of Secondary Surgical Interventions (SSIs)
Time frame: 24 Months post IC-8 Apthera IOL implantation
Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be assessed through 24 months post IC-8 Apthera IOL implantation
Rates of other serious adverse events
Time frame: 24 Months post IC-8 Apthera IOL implantation
Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation
Rates of ocular adverse events
Time frame: 24 Months post IC-8 Apthera IOL implantation
Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation
Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire
Time frame: 24 Months post IC-8 Apthera IOL implantation
Subjective responses to the QoV Questionnaire that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.
Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ)
Time frame: 24 Months post IC-8 Apthera IOL implantation
Subjective responses to the Small Aperture Patient Questionnaire (SAPQ) that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- 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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Presbyopia, run by Bausch & Lomb Incorporated at 14 sites in United States.
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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Laskowski (8183699137, jennifer.laskowski@bausch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment (time frame: 24 Months post IC-8 Apthera IOL Implantation). The study lists 8 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 12 Jan 2026.