Oval lenses may finally solve scleral lens discomfort
NCT ID NCT07288658
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether scleral lenses with an oval-shaped limbal zone fit better and feel more comfortable than traditional round designs. Seven existing scleral lens wearers tried both lens shapes, and researchers used advanced eye imaging to measure how well each lens cleared the limbus. The goal is to improve comfort and eye health for people who rely on scleral lenses daily.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Scleral lenses with oval and circular limbal zone designs
- What this could lead to
- If oval limbal zones fit better, this could lead to more comfortable and safer scleral lenses for daily wearers.
- What could go wrong
- This is a very small study (7 people) and only tests one lens brand. Results may not apply to all lens types or users.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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7 people
The number who actually took part.
- Started
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Jan 2026
- Finished
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Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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School of Optometry & Vision Science, University of Waterloo
Waterloo, Ontario, N2L 3G1, Canada
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