IC-8 Apthera IOL New Enrollment Post Approval 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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Presbyopia; Posterior Capsule Opacification

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 Type: Observational
• Enrollment (Estimated): 435

Contacts and Locations

• Study Contact: Name: Danni Fisher; Phone Number: 716-329-1162; Email: danni.fisher@bausch.com

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Recruiting
      • Trinity Research Group, LLC
      • Contact: Emily Ivey
      • Principal Investigator: Sebastian Heersink, MD
  • California
    • Chico, California, United States, 95926
      • Recruiting
      • Reeve Woods Eye Center
      • Contact: Emma Chauvin
      • Principal Investigator: David Woods, MD
  • Florida
    • Cape Coral, Florida, United States, 33909
      • Recruiting
      • Argus Research Center
      • Contact: Susana Perez
      • Principal Investigator: Cristos Ifantides, MD
      • Principal Investigator: Farrell Tyson, MD
  • Illinois
    • Rock Island, Illinois, United States, 61201
      • Not yet recruiting
      • Virdi Eye Clinic and Laser Vision Center
      • Contact: Mackensie Hook
      • Principal Investigator: Naveet Borisuth, MD, PhD
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Price Vision Group
      • Contact: Marianne Price
      • Principal Investigator: Francis Price Jr, MD
  • Minnesota
    • Alexandria, Minnesota, United States, 56308
      • Not yet recruiting
      • Vance Thompson Vision - Alexandria
      • Contact: Miranda Danielson
      • Principal Investigator: Brent Kramer, MD
  • Montana
    • Bozeman, Montana, United States, 59718
      • Not yet recruiting
      • Vance Thompson Vision - Bozeman
      • Contact: Briana Parker
      • Principal Investigator: Russell Swan, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68137
      • Not yet recruiting
      • Vance Thompson Vision - Omaha
      • Principal Investigator: Brandon Baartman, MD
      • Contact: Sarah Hartnett
  • New Jersey
    • South Orange, New Jersey, United States, 07079
      • Not yet recruiting
      • Northern New Jersey Eye Institute
      • Contact: Shirley Vitale
      • Principal Investigator: Charles Crane, MD
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Recruiting
      • Ophthalmic Partners, PC
      • Principal Investigator: Brandon Ayres, MD
      • Contact: James Wier
  • Texas
    • Sugar Land, Texas, United States, 77478
      • Recruiting
      • Berkeley Eye Center
      • Principal Investigator: Morgan Micheletti, MD
      • Contact: Diana Hill
  • Utah
    • Bountiful, Utah, United States, 84010
      • Not yet recruiting
      • Utah Eye Centers
      • Contact: Brittany Smith
      • Principal Investigator: Brock Hansen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nd:YAG laser technique details and/or settings	Nd:YAG laser technique and/or settings during treatment in an IC-8 Apthera intraocular lens (IOL) eye will be evaluated	PCO treatment visit (during the Nd:YAG laser procedure)
Investigator opinion of ease of YAG procedure	Difficulty performing Nd:YAG laser treatment in an IC-8 Apthera intraocular lens (IOL) eye will be evaluated per scale of difficulty chosen by investigator from 'No difficulty' to 'Great difficulty'	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)	Mean monocular and binocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes (same units of measure for all measurements)	24 Months post IC-8 Apthera IOL implantation
Mean monocular and binocular distance corrected distance visual acuity (DCDVA), distance corrected intermediate visual acuity (DCIVA) and distance corrected near visual acuity (DCNVA)	Mean monocular and binocular distance corrected distance visual acuity (DCDVA), distance corrected intermediate visual acuity (DCIVA) and distance corrected near visual acuity (DCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes (same units of measure for all measurements)	24 Months post IC-8 Apthera IOL implantation
Rates of device deficiencies	Rates of device deficiencies in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be evaluated	24 Months post IC-8 Apthera IOL implantation
Rates of loss of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of best corrected distance visual acuity (BCDVA)	The rates of each event of loss of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of best corrected distance visual acuity (BCDVA) between a study visit and a later study visit, the reason for the visual acuity loss, and the treatment/outcome of these instances will be assessed through 24 months post IC-8 Apthera intraocular lens (IOL) implantation	24 Months post IC-8 Apthera IOL implantation

Collaborators and Investigators

• Sponsor: AcuFocus, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 23, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia; Capsule Opacification
• Other Study ID Numbers: SAIL-101-PAS2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No