The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.

Inclusion criteria

Subjects who meet all of the following criteria are candidates for this study:

• Male or Female
• Any race
• Patient is at least 40 years old.
• Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
• Patient has manifest refraction, spherical equivalent (MRSE) between -0.50 D to 2.50 D, with no more than 1.0 D of refractive cylinder, in eye(s) to be treated.
• Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes.
• Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
• Patient has uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR < 0.70) in eye(s) to be treated.
• Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.
• Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.
• Patient is not a contact lens (CL) wearer.
• Patient has normal corneal topography.
• Patient is willing and able to comply with all examinations.
• Patient must be competent to sign an informed consent form before study entry.

Exclusion criteria

Subjects who meet any of the following criteria are to be excluded from this study:

• Corneal disease or corneal disorder in either eye.
• Any active ocular surface disease of any severity.
• Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.
• Previous corneal surgery in the eye to be treated.
• Conjunctivochalasis
• Nystagnus
• Diabetes
• Pregnancy
• Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.

nclusion Criteria: -

Exclusion criteria

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