Impact of Scleral Contact Lens Wear on Corneal Nerves in Keratoconus

NCT03091101 | Completed

• 1 other identifier: ORE#21910
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Keratoconus

Keywords

keratoconus; corneal innervation; scleral contact lenses

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Corneal inflammation

  6-month lens wear period

Study Arms (1)

Scleral lens wearing keratoconics

EXPERIMENTAL

Newly diagnosed keratoconics with no previous rigid lens wear fitted with Sceral contact lenses

Device: Scleral lens wearing keratoconics

Interventions

Scleral lens wearing keratoconics DEVICE

Cohort of keratoconics fitted with scleral lenses and monitored over 6 months

Scleral lens wearing keratoconics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have worn rigid corneal lenses for more than several days over the past year
• Is using any topical medications that will affect ocular health.
• Has any ocular pathology or systemic disease that may lead to severe insufficiency of lacrimal secretion (severe dry eyes) or corneal hypoesthesia which 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 and topical anesthetics, used in this study.

Sponsors & Collaborators

• University of Waterloo: lead
• Precision Technology Services Ltd: collaborator

Study Sites (1)

School of Optometry and Vision Science

Waterloo, Ontario, N2T2T3, Canada

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Edward Lum, PhD

  Univerity of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctorial Fellow

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 27, 2017
• Study Start: March 15, 2017
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-06

Locations

CA (1)