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

NCT03314766 | Completed

• 1 other identifier: IC-8 203-LTCA
• Study Type: observational
• Target: 64
• Locations: 4 countries
• Sites: 7

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.

Conditions

Cataract; Presbyopia

Outcome Measures

Primary Outcomes (1)

• TCNVA

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

  12 months

Secondary Outcomes (1)

• Overall Satisfaction

  12 months

Study Arms (1)

IC-8 IOL

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

Device: IC-8 IOL

Interventions

IC-8 IOL DEVICE

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

IC-8 IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures at the study visit.
• Signed informed consent.

You may not qualify if:

• \. 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. -

Sponsors & Collaborators

• AcuFocus, Inc.: lead

Study Sites (7)

Augen Zentrum Nordwest

Ahaus, 48683, Germany

Location

Universitats-Augenklinik, Department of Ophthalmology

Bochum, 44892, Germany

Location

San Bassano Hospital

Bassano del Grappa, 36061, Italy

Location

Centro Microchirurgia Ambulatoriale

Monza, 20900, Italy

Location

Ifocus Øyeklinikk

Haugesund, 5527, Norway

Location

QVision (Unidad Oftalmología Hospital Virgen del Mar)

Almería, 04120, Spain

Location

Hospital Universitario Donostia, Servicio de Oftalmología

Donostia / San Sebastian, 20014, Spain

Location

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Nicholas Tarantino, OD

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 19, 2017
• Study Start: October 20, 2017
• Primary Completion: November 27, 2018
• Study Completion: November 27, 2018
• Last Updated: May 13, 2022

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); ES (2); DE (2); IT (2)