Changes in the Tear Film With Scleral Contact Lens Wear for Keratoconic Eyes

Keratoconus Clinical Trial

Official title:

Protease and Cytokine Composition in Post Lens Tear Reservoir of Scleral Lenses for Keratoconic Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806921
• Other study ID #: 14620
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: February 15, 2018

Study information

• Verified date: June 2019
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 15, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Had been diagnosed with keratoconus in at least one eye.

• Is at least 18 years of age and has full legal capacity to volunteer.

• Has read and understood the information consent letter.

• Is willing and able to follow instructions and maintain the appointment schedule.

Exclusion Criteria:

• Is using any topical medications that will affect ocular health.

• Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses.

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.

• Has any clinically significant lid or conjunctival abnormalities and active neovascularization.

• Is aphakic.

• Has undergone any corneal surgery.

• Is participating in any other type of eye related clinical or research study.

• Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.

Related Conditions & MeSH terms

• Keratoconus

Intervention

Device:
• ZenLens
The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Bausch & Lomb Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	Bulbar and limbal hyperemia	The eyes of the participants will be imaged using the Keratograph® 5.	2 weeks of lens wear with daily schedule of 6-8 hours.
Secondary	Corneal thickness	Their corneal thickness will be measured with the Visante OCT.	2 weeks of lens wear with daily schedule of 6-8 hours.