IC-8 Apthera IOL New Enrollment Post Approval Study

NCT06060041 | Recruiting

• 1 other identifier: SAIL-101-PAS2
• Study Type: observational
• Target: 435
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Cataract; Presbyopia; Posterior Capsule Opacification

Outcome Measures

Primary Outcomes (8)

• 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

  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.

  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

  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

  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

  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

  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.

  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.

  24 Months post IC-8 Apthera IOL implantation

Other Outcomes (6)

• Nd:YAG laser technique details and/or settings

  PCO treatment visit (during the Nd:YAG laser procedure)

• Investigator opinion of ease of YAG procedure

  PCO treatment visit (during the Nd:YAG laser procedure)

• Mean monocular and binocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA)

  24 Months post IC-8 Apthera IOL implantation

Study Arms (1)

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.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (14)

Trinity Research Group, LLC

Dothan, Alabama, 36301, United States

RECRUITING

Feinerman Vision Center

Newport Beach, California, 92663, United States

RECRUITING

Argus Research Center

Cape Coral, Florida, 33909, United States

RECRUITING

Stephenson Eye Associates

Venice, Florida, 34285, United States

RECRUITING

Virdi Eye Clinic and Laser Vision Center

Rock Island, Illinois, 61201, United States

RECRUITING

Price Vision Group

Indianapolis, Indiana, 46260, United States

RECRUITING

Grene Vision Group

Wichita, Kansas, 67206, United States

RECRUITING

Oakland Eye

Birmingham, Michigan, 48009, United States

RECRUITING

Vance Thompson Vision - Omaha

Omaha, Nebraska, 68137, United States

RECRUITING

Eye Associates of New Jersey

Dover, New Jersey, 07801, United States

RECRUITING

Northern New Jersey Eye Institute

South Orange, New Jersey, 07079, United States

RECRUITING

Ophthalmic Partners, PC

Bala-Cynwyd, Pennsylvania, 19004, United States

RECRUITING

Berkeley Eye Center

Sugar Land, Texas, 77478, United States

RECRUITING

Utah Eye Centers

Bountiful, Utah, 84010, United States

RECRUITING

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Central Study Contacts

Jennifer Laskowski

CONTACT

8183699137; jennifer.laskowski@bausch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 29, 2023
• Study Start: September 8, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)