Post-Implant Performance of the EC-3 IOL

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Aaren Scientific Inc.
ClinicalTrials.gov Identifier:
NCT01333345
First received: April 8, 2011
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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.


Condition
Cataract

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Aaren Scientific Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who were enrolled in the EC-3 study and implanted with the EC-3 IOL.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333345

Locations
United States, Florida
Stephenson Eye Associates
Venice, Florida, United States, 34285
United States, New Hampshire
Eyesight Ophthalmic Services
Dover, New Hampshire, United States, 03820
France
Cabinet d'Ophtalmologie du Dr. Pey
Le Puy en Velay, France, 43000
Sponsors and Collaborators
Aaren Scientific Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: Robert Sheehan, VP of Regulatory Affairs & Quality Systems, Aaren Scientific Inc.
ClinicalTrials.gov Identifier: NCT01333345     History of Changes
Other Study ID Numbers: DC-036 Addendum
Study First Received: April 8, 2011
Last Updated: April 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Aaren Scientific Inc.:
Cataract replacement surgery
implantation
EC-3 IOL

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 22, 2014