Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens

The purpose of this study is to evaluate the long-term clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia
• Intervention / Treatment: Device: IC-8 IOL

Detailed Description

This will be a prospective, multi-center, non-interventional study in up to 80 patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 at up to nine clinical sites within Europe.

The purpose of this study is to demonstrate the long-term clinical acceptability and overall satisfaction in patients implanted with the IC-8 IOL. The primary study endpoint is binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients at least 12 months post-implantation. The secondary study endpoint is overall satisfaction with postoperative vision in 85% or more patients reporting either satisfied or very satisfied at least 12 months post-implantation.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Germany
  • Ahaus, Germany, 48683
    • Augen Zentrum Nordwest
  • Bochum, Germany, 44892
    • Universitats-Augenklinik, Department of Ophthalmology
• Italy
  • Bassano del Grappa, Italy, 36061
    • San Bassano Hospital
  • Monza, Italy, 20900
    • Centro Microchirurgia Ambulatoriale
• Norway
  • Haugesund, Norway, 5527
    • Ifocus øyeklinikk
• Spain
  • Almería, Spain, 04120
    • QVision (Unidad Oftalmología Hospital Virgen del Mar)
  • San Sebastian, Spain, 20014
    • Hospital Universitario Donostia, Servicio de Oftalmología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients for this study will be recruited from the clinical sites that participated in the prior open-label, multicenter study (protocol ACU-P14-029). Anticipated study sample size of no more than 80 patients should effectively demonstrate the long-term clinical acceptability of the IC-8 IOL implanted in aphakic patients.

Patients will be screened for eligibility, and an informed consent will be obtained from those who meet the screening criteria and are interested in participating in the study.

Description

Inclusion Criteria:

1. Patients previously implanted contralaterally or bilaterally with the IC-8 IOL under the protocol ACU-P14-029 and have had the IOL implanted for a duration of at least 12 months and currently have the IC-8 IOL in the eye.
2. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures at the study visit.
3. Signed informed consent.

Exclusion Criteria:

1. Patients who have developed systemic or ocular pathology, not related to the IOL that affected their best corrected distance visual acuity to be 0.8 decimal or worse as determined by diagnostic testing or investigator's medical judgment. -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IC-8 IOL; Patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029	Device: IC-8 IOL; Patients previously implanted with an IC-8 IOL contralaterally or bilaterally will be evaluated for their long-term visual functions and overall satisfaction at least 12 months post-implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TCNVA	Binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Satisfaction	Overall satisfaction with postoperative vision at least 12 months post-operatively, with an outcome of objective of 85% or more being either very satisfied or satisfied.	12 months

Collaborators and Investigators

• Sponsor: AcuFocus, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): November 27, 2018
• Study Completion (Actual): November 27, 2018

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: IC-8 203-LTCA

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
• product manufactured in and exported from the U.S.: Yes