Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation

NCT02826421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2018-07-02

Study results available
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Summary

The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system).

Conditions

  • Cataracts

Interventions

DEVICE

UltraSert Preloaded Delivery System

Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject

DEVICE

iTec Preloaded Delivery System

Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject

DEVICE

iSert Preloaded Delivery System

Includes Model 251 or Model 250 posterior chamber IOL, as selected by the Investigator, intended for long term use over the lifetime of the subject

DEVICE

Monarch III D Manual IOL Delivery System

Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Sr. Clinical Manager, GCRA · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-04
Primary Completion
2016-11-29
Completion
2016-11-29
FDA Device
Yes

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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 NCT02826421 on ClinicalTrials.gov