Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)

Post-approval Follow-up Study of the IC-8 Apthera IOL

The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia

Detailed Description

A prospective, multi-center, open-label, single-group, post-approval follow-up study of IC-8 Apthera intraocular lens (IOL) subjects previously implanted with the IC-8 Apthera IOL in the Investigational Device Exemption (IDE) clinical study (G180075). All subjects will undergo one scheduled study visit, which is the 3-year post IC-8 Apthera IOL implantation visit. There is one study group: subjects enrolled in the US IDE study (G180075) and implanted with the IC-8 Apthera IOL.

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye & Laser Center
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates
    • Los Altos, California, United States, 94024
      • Altos Eye Physicians
    • Los Angeles, California, United States, 90067
      • Advanced Vision Care
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Eye Center of Northern Colorado
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Chu Vision Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Pepose Vision Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68118
      • Kugler Vision
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Alterman, Modi & Wolter
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Physicians Protocol
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19148
      • Philadelphia Eye Associates
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision
  • Utah
    • Draper, Utah, United States, 84021
      • Hoopes Vision
    • Ogden, Utah, United States, 84403
      • Utah Eye Centers
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Potential study subjects will be recruited from patients previously enrolled in the IC-8 Apthera intraocular lens (IOL) Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL.

Description

Inclusion Criteria:

• Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)
• 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 visit(s)

Exclusion Criteria:

• There are no exclusion criteria for this study

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 enrolled in the IC-8 Apthera IOL Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of secondary surgical interventions (SSIs)	Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit	3 years 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 will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit	3 years 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 will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit	3 years post IC-8 Apthera IOL implantation
Rates of subjective visual disturbances	Rates of subjective visual disturbances will be assessed using responses to patient Reported Outcomes (PRO) and responses to non-directed question(s)	3 years post IC-8 Apthera IOL implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular best-corrected distance visual acuity (BCDVA) in IC-8 Apthera eyes and fellow eyes	Monocular best-corrected distance visual acuity will be assessed at the Study visit in the IC-8 Apthera intraocular lens (IOL) eyes and in the fellow eyes	3 years post IC-8 Apthera IOL implantation
Rate of intraocular lens (IOL) removals due to visual/optical reasons in the IC-8 Apthera eyes and fellow eyes	Rate of intraocular lens (IOL) removals (based on eyes with events) will be assessed at the Study visit in the IC-8 Apthera IOL eyes and in the fellow eyes	3 years post IC-8 Apthera IOL implantation
Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA)	Mean monocular 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	3 years post IC-8 Apthera IOL implantation
Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA)	Mean 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	3 years post IC-8 Apthera IOL implantation
Uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) in IC-8 Apthera eyes and the fellow eyes in postoperative Manifest Refraction Spherical Equivalent (MRSE) groups	Uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) in IC-8 Apthera eyes and the fellow eyes may be evaluated in postoperative Manifest Refraction Spherical Equivalent groups: -1.01 D to more myopic, -1.00 D to -0.50 D, -0.49 D to -0.25 D, -0.24 D to 0.00 D, +0.01 D to +0.25 D, +0.26 D to more hyperopic.	3 years post IC-8 Apthera IOL implantation

Collaborators and Investigators

• Sponsor: AcuFocus, Inc.
• Investigators: Study Director: Magda Michna, Ph.D., AcuFocus, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Actual): February 16, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

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

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