Impact of Scleral Contact Lens Wear on Corneal Nerves in Keratoconus
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|ClinicalTrials.gov Identifier: NCT03091101|
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus||Device: Scleral lens wearing keratoconics||Not Applicable|
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:
- Measure corneal sensitivity at two corneal locations before and after 1-month, 3-months and 6-months of scleral lens wear.
- Capture images of the sub-basal nerve plexus in vivo using laser-scanning confocal microscopy at similar corneal locations and study visits.
- Calculate nerve morphology parameters and dendritic cell density from these captured images.
Up to 15 participants will be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Scleral Contact Lens Wear on Corneal Sensitivity, Nerve Morphology and Inflammation in Keratoconic Eyes|
|Actual Study Start Date :||March 15, 2017|
|Actual Primary Completion Date :||March 21, 2018|
|Actual Study Completion Date :||March 21, 2018|
Experimental: Scleral lens wearing keratoconics
Newly diagnosed keratoconics with no previous rigid lens wear fitted with Sceral contact lenses
Device: Scleral lens wearing keratoconics
Cohort of keratoconics fitted with scleral lenses and monitored over 6 months
- Corneal sensitivity [ Time Frame: 6-month lens wear period ]Indication of functional change in corneal innervation from scleral lens wear by measuring change in sensitivity threshold (grams/sq.mm) over time
- Subbasal nerve fiber density [ Time Frame: 6-month lens wear period ]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.
- Corneal inflammation [ Time Frame: 6-month lens wear period ]Changes in dendritic cell density (number/sq.mm) as a marker of corneal inflammation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091101
|School of Optometry and Vision Science|
|Waterloo, Ontario, Canada, N2T2T3|
|Principal Investigator:||Edward Lum, PhD||Univerity of Waterloo|