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Comparing the Fit and Performance of Scleral Lenses With Oval and Circular Limbal Zones

NCT07288658 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-05-05

No results posted yet for this study

Summary

Scleral lenses are large, rigid contact lenses that rest on the white part of the eye and arch over the cornea. They are commonly used to improve vision in people with eye conditions like keratoconus or corneal scarring, but are increasingly popular among people with high prescriptions or dry eyes due to the comfort and clarity they provide.

While these lenses offer many benefits, fitting them properly can be difficult, especially over the limbus, the border between the clear front surface of the eye and the white part of the eye. This area is home to important stem cells that help keep the eye healthy. Most lenses today are designed to fit the limbus as if it were perfectly round, but new research shows the limbus is actually more oval-shaped. When scleral lenses do not match this shape, they may press too hard in some areas or leave too much space in other areas of the limbus, potentially causing discomfort or long-term eye health problems.

This study will test whether lenses designed with an oval-shaped limbal zone provide a better fit and greater comfort than traditional round designs. To do this, advanced eye imaging and computer modelling will be used to measure the limbus and customize scleral lens design for each participant.

All lenses used in the study are already approved and available in Canada. The results may help improve lens comfort and safety for people who rely on scleral lenses every day.

Conditions

  • Limbus Corneae

Interventions

DEVICE

Scleral lenses

Scleral lenses designed with oval and circular limbal zone designs

Sponsors & Collaborators

  • Fighting Blindness Canada

    collaborator UNKNOWN

  • Canadian Optometric Education Trust Fund (COETF)

    collaborator UNKNOWN

  • University of Waterloo

    lead OTHER

Principal Investigators

  • Lyndon Jones, PhD, FCOptom · University of Waterloo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2026-03-18
Completion
2026-03-18

Countries

  • Canada

Study Locations

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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 NCT07288658 on ClinicalTrials.gov