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

NCT ID: NCT02806921

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-02-15

Brief 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.

Detailed 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.

Conditions

Keratoconus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ZenLens with Low limbal clearance

Scleral contact lens designed to provide approximately 25 microns of limbal clearance.

Group Type: ACTIVE_COMPARATOR

ZenLens

Intervention Type: DEVICE

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

ZenLens with High limbal clearance

Scleral contact lens designed to provide approximately 80 microns of limbal clearance.

Group Type: ACTIVE_COMPARATOR

ZenLens

Intervention Type: DEVICE

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

Interventions

ZenLens

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Luigina Sorbara

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14620

Identifier Type: -

Identifier Source: org_study_id