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Comparison of Gemini III Rev 2 Implanted in Conjunction With an Approved IOL vs Eyes Implanted With an Approved IOL

NCT04059796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-09-16

No results posted yet for this study

Summary

This study is a prospective, observational, randomized, controlled, paired eye, subject-masked design.

Conditions

  • Cataract

Interventions

DEVICE

Omega Gemini III Rev 2 Device

Eyes randomized to receive the Gemini III Rev 2 device will receive the study device in conjunction with an approved monofocal or toric IOL post cataract extraction

DEVICE

Control Eye

Control eyes will receive an approved monofocal or toric IOL post cataract extraction

Sponsors & Collaborators

  • Omega Ophthalmics

    lead INDUSTRY

Principal Investigators

  • Claudio Orlich, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-21
Primary Completion
2020-08-28
Completion
2020-08-28

Countries

  • Costa Rica

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 NCT04059796 on ClinicalTrials.gov