Astigmatism
Conditions
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.
Interventions
DEVICEAstigmatic Correction Lens (Nexis ACCL lenses)
Astigmatic refractive error correction
DEVICEToric Soft Contact Lenses
astigmatism correction using toric optics
Sponsors
FORSIGHT Vision3
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Acuity | 30 mins |
Countries
United States
Outcome results
None listed