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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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The purpose of this study is to investigate changes in the level of inflammatory mediators in the tear film of scleral contact lens wearers in a keratoconic population.
Scleral contact lenses are rigid gas permeable lenses designed to rest on the sclera while vaulting over the cornea with a fluid reservoir. The use of scleral contact lenses has become the current standard of practice as a nonsurgical management of corneal ectasia and ocular surface diseases. Cases have been recently presented of scleral lens wearers exhibiting adverse corneal findings and conjunctival injection from lens wear. These findings are likely associated with the mechanical and hypoxic effects due to poor fitting characteristics at the limbal area. Tear film analysis detecting changes in the levels of proteinases and cytokines have helped researchers gain a better understanding of the pathophysiology of complications in soft contact lenses wearers, dry eye, and keratoconus. Ultimately, this study will provide insights in relating scleral lens fitting characteristics and corneal and limbal physiological responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZenLens with Low limbal clearance | Active Comparator | Scleral contact lens designed to provide approximately 25 microns of limbal clearance. |
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| ZenLens with High limbal clearance | Active Comparator | Scleral contact lens designed to provide approximately 80 microns of limbal clearance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZenLens | Device | The ZenLensâ„¢ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tear Protein | To measure the level proteases and cytokines in each of the samples using Meso Scale Discovery system (MSD-ECL). | 2 weeks of lens wear with daily schedule of 6-8 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Participants will be asked to rate their ocular comfort, dryness, burning and vision with the contact lenses. | 2 weeks of lens wear with daily schedule of 6-8 hours. |
| Bulbar and limbal hyperemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2016 | Mar 20, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2016 | Jun 25, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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The eyes of the participants will be imaged using the Keratograph® 5.
| 2 weeks of lens wear with daily schedule of 6-8 hours. |
| Corneal thickness | Their corneal thickness will be measured with the Visante OCT. | 2 weeks of lens wear with daily schedule of 6-8 hours. |