Post-Implant Performance of the EC-3 IOL
|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|