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

This study is currently recruiting participants.

Verified by The New York Eye & Ear Infirmary, September 2005

Sponsors and Collaborators:	The New York Eye & Ear Infirmary Ophtec USA
Information provided by:	The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:	NCT00201604

Purpose

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.

Condition	Intervention	Phase
Photophobia Visual Disturbances	Device: Model 311	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	Ophtec Model 311 Iris Reconstruction Lens for the Treatment of Visual Disturbances Resulting From Partial or Total Absence of the Human Iris

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201604

Contacts

Contact: Kenneth J Rosenthal, M.D

516-466-8989

kenrosenthal@eyesurgery.org

Locations

United States, New York
Rosenthal Eye and Facial Plastic Surgery	Recruiting
310 E. Shore Road, Greatneck, New York, United States, 11023
Contact: Kenneth J Rosenthal, M.D 516-466-8989 kenrosenthal@eyesurgery.org

Sponsors and Collaborators

The New York Eye & Ear Infirmary

Ophtec USA

Investigators

Principal Investigator:

Kenneth J Rosenthal, M.D

Rosenthal Eye and Facial Plastic Surgery

More Information

Study ID Numbers:	Ophtec USA
Study First Received:	September 15, 2005
Last Updated:	March 21, 2006
ClinicalTrials.gov Identifier:	NCT00201604
Health Authority:	United States: Food and Drug Administration

Keywords provided by The New York Eye & Ear Infirmary:

Iris Reconstruction
Iris Implant
visual disturbances
Glare
Halos

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Vision Disorders

Eye Diseases
Neurologic Manifestations
Photophobia

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009