Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses

Inclusion Criteria

• Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
• Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day.
• The prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
• Subjects must have best spectacle corrected visual acuity of at least 0.5 logMAR in each eye.
• Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing).

Exclusion Criteria

• Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
• Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.

Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.

• Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
• Subjects who are participating in any other clinical trial (FDA or other)