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IOL Implantation After KAMRA Inlay Removal

NCT03320473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-05-10

No results posted yet for this study

Summary

A. The primary purpose of the study is to evaluate outcomes of aphakic eyes implanted with the IC-8 IOL following cataract removal in prior inlay patients after KAMRA inlay removal.

B. The secondary purpose of the study is to determine whether there are any changes in biometry measurements before and after the inlay removal and how the changes affect the calculated IOL power.

Conditions

Interventions

DEVICE

IC-8 IOL

The AcuFocus IC-8 intraocular lens (IC-8 IOL) is a one-piece hydrophobic acrylic posterior chamber IOL into which a circular mask with a small 1.36 mm central aperture has been embedded. The IOL mask works by extending the depth of focus and its design is based on the KAMRA corneal inlay, which operates under the principle of small aperture optics.

Sponsors & Collaborators

  • AcuFocus, Inc.

    lead INDUSTRY

Principal Investigators

  • Nicholas Tarantino, OD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-05
Primary Completion
2022-06-20
Completion
2022-06-20

Countries

  • Philippines

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03320473 on ClinicalTrials.gov