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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314766
• Other study ID #: IC-8 203-LTCA
• Status: Completed
• Start date: October 20, 2017
• Est. completion date: November 27, 2018

Study information

• Verified date: July 2018
• Source: AcuFocus, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

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

Locations

Country	Name	City	State
Germany	Augen Zentrum Nordwest	Ahaus
Germany	Universitats-Augenklinik, Department of Ophthalmology	Bochum
Italy	San Bassano Hospital	Bassano del Grappa
Italy	Centro Microchirurgia Ambulatoriale	Monza
Norway	Ifocus Øyeklinikk	Haugesund
Spain	QVision (Unidad Oftalmología Hospital Virgen del Mar)	Almería
Spain	Hospital Universitario Donostia, Servicio de Oftalmología	San Sebastian

Sponsors (1)

Lead Sponsor	Collaborator
AcuFocus, Inc.

Countries where clinical trial is conducted

Germany,  Italy,  Norway,  Spain, 

Outcome

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