Post-Implant Performance of the EC-3 IOL
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|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|
- To evaluate the presence, if any, of PCO (Posterior Capsule Opacification) in the EC-3 lens. [ Time Frame: 2-3 years post-implantation ] [ Designated as safety issue: No ]Routine eye exam by the investigator.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333345
|United States, Florida|
|Stephenson Eye Associates|
|Venice, Florida, United States, 34285|
|United States, New Hampshire|
|Eyesight Ophthalmic Services|
|Dover, New Hampshire, United States, 03820|
|Cabinet d'Ophtalmologie du Dr. Pey|
|Le Puy en Velay, France, 43000|
|Principal Investigator:||P. Dee G. Stephenson, M.D.||Stephenson Eye Associates|
|Principal Investigator:||N. Timothy Peters, M.D.||Eyesight Ophthalmic Services PA|
|Principal Investigator:||Christophe Pey, M.D.||Cabinet d'Ophtalmologie du Dr. Pey|