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

Completed

• Conditions: Cataract; Presbyopia
• Interventions: Device: IC-8 IOL

• Registration Number: NCT03314766
• Lead Sponsor: AcuFocus, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-19
• Study Start: 2017-10-20
• Status Verified: 2018-07
• Primary Completion: 2018-11-27
• Study Completion: 2018-11-27
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IC-8 IOL	IC-8 IOL	Patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall Satisfaction	12 months	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.

Trial Locations

Locations (7)

Ifocus Øyeklinikk; 🇳🇴 Haugesund, Norway

Augen Zentrum Nordwest; 🇩🇪 Ahaus, Germany

Universitats-Augenklinik, Department of Ophthalmology; 🇩🇪 Bochum, Germany

Hospital Universitario Donostia, Servicio de Oftalmología; 🇪🇸 San Sebastian, Spain

San Bassano Hospital; 🇮🇹 Bassano del Grappa, Italy

Centro Microchirurgia Ambulatoriale; 🇮🇹 Monza, Italy

QVision (Unidad Oftalmología Hospital Virgen del Mar); 🇪🇸 Almería, Spain