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

Study Overview
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Brief Summary
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This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.

Conditions
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Scleral Lens Wearers

Intervention / Treatment
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* Device: scleral contact lens


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens fitting/evaluation<br>This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month. | Device: scleral contact lens<br>* Scleral contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses | Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses | 1 month after lens is dispensed |