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Corneal Thickness Changes With Scleral Contact Lenses

NCT03249233 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-04-10

No results posted yet for this study

Summary

The purpose of this study is to investigate changes in the corneal thickness of scleral contact lens wearers in a keratoconic (KC) population and compare to age-matched controls. The hypothesis is that scleral contact lens wear is associated with low levels of corneal hypoxia including measurable changes in corneal thickness. Corneal thickness will be altered post scleral lens wear compared to pre-lens wear and the amount of alteration will correlate to the fitting characteristics in the central zone of the scleral lenses. We propose to take a sample of keratoconic and control participants, fit them in scleral lenses, and to measure topographic corneal thickness after 8-10 hours of scleral lens wear after three weeks of wear, to compare two instruments in the measurement of corneal thickness, and to compare the effects of varying central corneal clearance of the scleral lens on corneal thickness.

Conditions

  • Keratoconus
  • Healthy Controls

Interventions

DEVICE

ZenLens™

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

DEVICE

Zen™ RC

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

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    collaborator INDUSTRY

  • University of Waterloo

    lead OTHER

Principal Investigators

  • Luigina Sorbara, OD MSc · University of Waterloo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03249233 on ClinicalTrials.gov