ZenLens
DeviceThe ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
NCT Number: NCT02806921
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
Time frame: 2 weeks of lens wear with daily schedule of 6-8 hours.
To measure the level proteases and cytokines in each of the samples using Meso Scale Discovery system (MSD-ECL).
Time frame: 2 weeks of lens wear with daily schedule of 6-8 hours.
Participants will be asked to rate their ocular comfort, dryness, burning and vision with the contact lenses.
Time frame: 2 weeks of lens wear with daily schedule of 6-8 hours.
The eyes of the participants will be imaged using the Keratograph® 5.
Time frame: 2 weeks of lens wear with daily schedule of 6-8 hours.
Their corneal thickness will be measured with the Visante OCT.
University of Waterloo
Other
Protease and Cytokine Composition in Post Lens Tear Reservoir of Scleral Lenses for Keratoconic Eyes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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