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Post-Implant Performance of the EC-3 IOL

A

Aaren Scientific

Status

Unknown

Conditions

Cataract

Study type

Observational

Funder types

Industry

Identifiers

NCT01333345
DC-036 Addendum

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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