Clinical trial NCT03314766: Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens
Official title: Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Presbyopia
Lead sponsor: AcuFocus, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: TCNVA
timeFrame: 12 months
Secondary outcomes:
measure: Overall Satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Ahaus
country: Germany
facility: Augen Zentrum Nordwest
city: Bochum
country: Germany
facility: Universitats-Augenklinik, Department of Ophthalmology
city: Bassano del Grappa
country: Italy
facility: San Bassano Hospital
city: Monza
country: Italy
facility: Centro Microchirurgia Ambulatoriale
city: Haugesund
country: Norway
facility: Ifocus Øyeklinikk
city: Almería
country: Spain
facility: QVision (Unidad Oftalmología Hospital Virgen del Mar)
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia, Servicio de Oftalmología
Study officials:
name: Nicholas Tarantino, OD
role: STUDY_DIRECTOR
References: