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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03314766

Enrollment

Registered

2017-10-19

Start date

2017-10-20

Completion date

2018-11-27

Last updated

2022-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Presbyopia

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.

Interventions

DEVICEIC-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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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. -

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Germany, Italy, Norway, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026