Evaluation Study on Corneal Lens for Vision Correction

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Astigmatic Correction Lens (Nexis ACCL lenses); Device: Toric Soft Contact Lenses

• Registration Number: NCT02053688
• Lead Sponsor: FORSIGHT Vision3

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-01
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-02-02
• Last Update Submitted: 2014-02-02
• Study First Posted: 2014-02-04
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patient with good corneal health
2. Age 18-65.
3. 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.
4. Best corrected visual acuity of 20/20 or better in the study eye/s

Exclusion Criteria

1. Any other anterior segment abnormality.
2. No previous corneal procedures, including Laser Vision Correction.
3. Any abnormalities associated with the eye lids.
4. Clinically significant inflammation or infection within six (6) months prior to study.
5. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
6. 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.
7. Intolerance or hypersensitivity to topical anesthetics, fluorescein, or components of the material.
8. Specifically known intolerance or hypersensitivity to contact lenses.
9. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Astigmatic Correction Lens	Astigmatic Correction Lens (Nexis ACCL lenses)	Nexis ACCL lenses vs commercial Toric Lenses
Toric Soft Contact Lenses	Toric Soft Contact Lenses	commercial toric soft contact lenses

Primary Outcome Measures

Name	Time	Method
Visual Acuity	30 mins

Trial Locations

Locations (6)

John Michelsen; 🇺🇸 Livermore, California, United States

Josephine Vo-Laurel; 🇺🇸 Stockton, California, United States

Nexis Vision; 🇺🇸 Menlo Park, California, United States

Nick Chan; 🇺🇸 San Mateo, California, United States

Sara Chiu; 🇺🇸 Fremont, California, United States

Cliff Leong; 🇺🇸 Fremont, California, United States