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

NCT07288658 | Completed Phase 4

• 1 other identifier: 47580
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

limbus; scleral lens

Outcome Measures

Primary Outcomes (1)

• Limbal clearance in 4 semi-meridians (superior, nasal, inferior and temporal) of a scleral lens

  Measured in microns on an Anterion anterior segment OCT scan using the built-in calipers.

  at the Follow-up Visits 2 weeks and 4 weeks after the start of the study

Study Arms (2)

Scleral lenses with an oval limbal zone

EXPERIMENTAL

Scleral lenses with an oval limbal zone designed with a scleral lens custom design software (WAVE Contact Lens System)

Device: Scleral lenses

Scleral lenses with a circular limbal zone

ACTIVE COMPARATOR

Scleral lenses with a circular limbal zone designed with a scleral lens custom design software (WAVE Contact Lens System)

Device: Scleral lenses

Interventions

Scleral lenses DEVICE

Scleral lenses designed with oval and circular limbal zone designs

Scleral lenses with a circular limbal zone; Scleral lenses with an oval limbal zone

Eligibility Criteria

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

You may qualify if:

• Are at least 18 years of age and has full legal capacity to volunteer;
• Have signed an information consent letter;
• Are willing and able to follow instructions and maintain the appointment schedule;
• Are existing wearers of WAVE ScleraLens in one or both eyes.

You may not qualify if:

• Are participating in any concurrent clinical or research study;
• Have any known active\* ocular disease and/or infection;
• Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• Have taken part in another (pharmaceutical) research study within the last 30 days; \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Sponsors & Collaborators

• University of Waterloo: lead
• Fighting Blindness Canada: collaborator
• Canadian Optometric Education Trust Fund (COETF): collaborator

Study Sites (1)

School of Optometry & Vision Science, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

Study Officials

• Lyndon Jones, PhD, FCOptom

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: December 17, 2025
• Study Start: January 13, 2026
• Primary Completion: March 18, 2026
• Study Completion: March 18, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-12

Locations

CA (1)