CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 453 enrolled
Drug / intervention
IC-8 IOL Group +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03633695
NCT03633695N/ACompleted
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Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

AcuFocus, Inc.·interventional·Posted Aug 16, 2018·Updated Oct 24, 2022

In Brief

A clinical study evaluating IC-8 IOL Group and Control Group for Cataract and Presbyopia. Completed, enrolled 453 participants across 21 sites.

Detailed Summary

The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract, Presbyopia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 16, 2018
Enrollment StartDec 4, 2018
Primary CompletionOct 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.9 years ago

Interventions

IC-8 IOL Groupdevice

A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye for use over the lifetime of the patient. The IC-8 IOL implanted in the second eye for use over the lifetime of the patient.

Control Groupdevice

A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.