Ophtec Iris Reconstruction Lens Implant Model 311 for the Treatment of Visual Disturbances - Tabular View

Tracking Information

First Received Date ^ICMJE

September 15, 2005

Last Updated Date

March 21, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00201604 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Ophtec Iris Reconstruction Lens Implant Model 311 for the Treatment of Visual Disturbances

Official Title ^ICMJE

Ophtec Model 311 Iris Reconstruction Lens for the Treatment of Visual Disturbances Resulting From Partial or Total Absence of the Human Iris

Brief Summary

The objective of this study is to determine the safety and effectiveness of Model 311 Iris Reconstruction Lens for the treatment of visual disturbances (glare, halos, photophobia etc.) that are related to the absence of all or part of the human iris.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Open Label, Active Control, Single Group Assignment

Condition ^ICMJE

Photophobia
Visual Disturbances

Intervention ^ICMJE

Device: Model 311

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

21 years old or older
Must have a partially or totally missing iris or other significant iris defect
Experience clinically significant and measurable visual disturbance
Aphakic, pseudophakic or will have natural lens extracted due to cataract or trauma

Exclusion Criteria:

Patients that are not able to meet the extensive postoperative evaluation requirements
Mentally retarded
Stargardt's retinopathy, gastric ulcers or diabetic mellitus
Surgical difficulty at the time of surgery
Chronic recurrent uveitis or history of the same
Not expected to achieve a postoperative corrected visual acuity of 20/62 or better
Immuno-compromised by steroids and/or antimetabolites
Contralateral eye decompensation
Allergy to operative and/or postoperative medication
Pregnant or lactating women
High preoperative intraocular pressure, >21 mm Hg

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kenneth J Rosenthal, M.D

516-466-8989

kenrosenthal@eyesurgery.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00201604

Responsible Party

Study ID Numbers ^ICMJE

Ophtec USA

Study Sponsor ^ICMJE

The New York Eye & Ear Infirmary

Collaborators ^ICMJE

Ophtec USA

Investigators ^ICMJE

Principal Investigator:

Kenneth J Rosenthal, M.D

Rosenthal Eye and Facial Plastic Surgery

Information Provided By

The New York Eye & Ear Infirmary

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP