Post-Implant Performance of the EC-3 IOL

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01333345
• Other study ID #: DC-036 Addendum
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 8, 2011
• Last updated: April 11, 2011
• Start date: April 2011
• Est. completion date: June 2011

Study information

• Verified date: April 2011
• Source: Aaren Scientific Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
France	Cabinet d'Ophtalmologie du Dr. Pey	Le Puy en Velay
United States	Eyesight Ophthalmic Services	Dover	New Hampshire
United States	Stephenson Eye Associates	Venice	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aaren Scientific Inc.

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the presence, if any, of PCO (Posterior Capsule Opacification) in the EC-3 lens.	Routine eye exam by the investigator.	2-3 years post-implantation	No