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Investigation of the Safety and Effectiveness of a Trifocal IOL

NCT04176965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 539

Last updated 2025-01-29

Study results available
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Summary

This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available monofocal IOL.

Conditions

  • Eye Diseases
  • Postcataract Aphakia
  • Cataract
  • Lens Opacities

Interventions

DEVICE

FINEVISION HP IOL

Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.

DEVICE

Alcon AcrySof SN60AT

Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.

Sponsors & Collaborators

  • Beaver-Visitec International, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2024-05-13
Completion
2024-05-13
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04176965 on ClinicalTrials.gov