Post-Implant Performance of the EC-3 IOL

NCT ID: NCT01333345

Last Updated: 2011-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted. The primary aim of the study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies in the subjects.

Detailed Description

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Anomalies include, but are not limited to:

Posterior Capsule Opacification (PCO) (pathological condition) - delayed clouding of the lens capsule after cataract surgery.

Glistenings - fluid-filled micro-vacuoles that form within the intraocular lens (IOL) optic when the IOL is in an aqueous environment. They may appear to be on the lens surface.

Artifacts - glares, halos, starbursts and/or shadows caused by IOLs.

Fibrosis - the formation of fibrous connective tissue, as in a scar.

Glare - undesirable sensation produced by brightness that is much greater than that to which the eyes are adapted. Causes annoyance, discomfort, or loss in visual performance.

Halos (symptom) - the appearance of hazy ring(s) around light.

Conditions

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Cataract

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Enrollment in the EC-3 clinical trial
* Subjects who were implanted with EC-3 IOL

Exclusion Criteria

* Removal of the EC-3 IOL at any time
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aaren Scientific Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Aaren Scientific Inc.

Principal Investigators

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P. Dee G. Stephenson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stephenson Eye Associates

N. Timothy Peters, M.D.

Role: PRINCIPAL_INVESTIGATOR

Eyesight Ophthalmic Services PA

Christophe Pey, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cabinet d'Ophtalmologie du Dr. Pey

Locations

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Stephenson Eye Associates

Venice, Florida, United States

Site Status

Eyesight Ophthalmic Services

Dover, New Hampshire, United States

Site Status

Cabinet d'Ophtalmologie du Dr. Pey

Le Puy-en-Velay, , France

Site Status

Countries

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United States France

Other Identifiers

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DC-036 Addendum

Identifier Type: -

Identifier Source: org_study_id

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