Post-Implant Performance of the EC-3 IOL

Post-Implant Performance of the EC-3 IOL ADDENDUM TO THE PROTOCOL: Clinical Evaluation of the EC-3 Hydrophobic Acrylic Posterior Chamber Aphakic Intraocular Lens

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01333345

Enrollment

100

Registered

2011-04-12

Start date

2011-04-30

Completion date

2011-06-30

Last updated

2011-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Cataract replacement surgery, implantation, EC-3 IOL

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the presence, if any, of PCO (Posterior Capsule Opacification) in the EC-3 lens.	2-3 years post-implantation	Routine eye exam by the investigator.

Countries

France, United States

Outcome results