Evaluation Study on Corneal Lens for Vision Correction

FORSIGHT Vision36 sites in 1 country40 target enrollmentFebruary 2013

ConditionsAstigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Astigmatism
Sponsor: FORSIGHT Vision3
Enrollment: 40
Locations: 6
Primary Endpoint: Visual Acuity
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens, made of silicone commonly used in the contact lens industry, on healthy eye with or without astigmatism.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

December 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

FORSIGHT Vision3

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient with good corneal health
•Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements.
•Best corrected visual acuity of 20/20 or better in the study eye/s

Exclusion Criteria

•Any other anterior segment abnormality.
•No previous corneal procedures, including Laser Vision Correction.
•Any abnormalities associated with the eye lids.
•Clinically significant inflammation or infection within six (6) months prior to study.
•Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
•Participation in any study involving an investigational drug or device within the past 30 calendar days, or ongoing participation in a study with an investigational material except studies using corneal lenses.
•Intolerance or hypersensitivity to topical anesthetics, fluorescein, or components of the material.
•Specifically known intolerance or hypersensitivity to contact lenses.
•Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.