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| Name | Class |
|---|---|
| Precision Technology Services Ltd | UNKNOWN |
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The purpose of this study is to investigate changes in corneal innervation during scleral contact lens wear in a keratoconic population. Specifically, changes in corneal sensitivity and nerve fiber density from baseline in the central and mid-peripheral corneal locations will be measured over a 6-month lens wear period. An additional aim of the study is to investigate the impact of scleral lens wear on corneal inflammation within the same study group. This will be achieved by comparing dendritic cell density change from baseline over the study period.
The human cornea is a densely innervated tissue that provides a high level of sensitivity to foreign objects or noxious substances. The innervation of the cornea also plays an important role in the tropic maintenance and repair of the corneal surface. Any alterations to the normal innervation of the cornea not only lessen the ability to detect foreign objects that could damage the ocular surface, but also reduce its wound healing ability. Previous studies have shown rigid contact lens wear reduces corneal sensitivity and nerve fiber density in keratoconic subjects. Scleral contact lenses are large diameter rigid gas permeable lenses that rests on the sclera while vaulting over the cornea with a fluid reservoir. The use of scleral contact lenses is becoming one of the current standard nonsurgical management of corneal dystrophies such as keratoconus, mainly due to the improved comfort and vision quality compared to conventional rigid lenses. Despite these patient benefits, little is known about the impact of scleral contact lens wear on corneal sensitivity and nerve morphology in keratoconus.
The purpose of this study is to investigate changes in corneal innervation during scleral contact lens wear in a keratoconic population. Specifically, changes in corneal sensitivity and nerve fiber density from baseline in the central and mid-peripheral corneal locations will be measured over a 6-month lens wear period. An additional aim of the study is to investigate the impact of scleral lens wear on corneal inflammation within the same study group. This will be achieved by comparing dendritic cell density change from baseline over the study period.
The investigators propose to take a sample of keratoconic participants and fit them in scleral lenses and:
Up to 15 participants will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scleral lens wearing keratoconics | Experimental | Newly diagnosed keratoconics with no previous rigid lens wear fitted with Sceral contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scleral lens wearing keratoconics | Device | Cohort of keratoconics fitted with scleral lenses and monitored over 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal sensitivity | Indication of functional change in corneal innervation from scleral lens wear by measuring change in sensitivity threshold (grams/sq.mm) over time | 6-month lens wear period |
| Subbasal nerve fiber density | Indication of morphological change in corneal innervation from scleral lens wear by measuring nerve fiber density changes (mm/sq.mm) in the central subbasal nerve fiber layer location over time. | 6-month lens wear period |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal inflammation | Changes in dendritic cell density (number/sq.mm) as a marker of corneal inflammation | 6-month lens wear period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Lum, PhD | Univerity of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry and Vision Science | Waterloo | Ontario | N2T2T3 | Canada |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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