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The effect of scleral lens channels on tear flow in adults with healthy eyes

The effect of scleral contact lens channels on tear flow in adults with healthy eyes

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000047594
Enrollment
6
Registered
2024-01-19
Start date
2024-03-01
Completion date
2024-04-30
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to assess the effect of adding channels to scleral contact lenses upon corneal tissue swelling and tear flow behind the contact lens in young healthy adults during short-term lens wear (6 hours). The null hypothesis is that the incorporation of scleral lens channels will have no significant effect upon the primary outcome measures.

Interventions

The intervention is a scleral contact lens with landing zone modifications (channels). All lenses will be fitted to each individual eye and assessed by contact lens practitioners with over 10 years of experience. Scleral lenses will be worn in one eye for one 6 hour session in a research laboratory/clinical facility. The order of lens wear (intervention/control) will be randomized. The intervention and control lenses will be worn on different days with at least one day without contact lens wear

The intervention is a scleral contact lens with landing zone modifications (channels). All lenses will be fitted to each individual eye and assessed by contact lens practitioners with over 10 years of experience. Scleral lenses will be worn in one eye for one 6 hour session in a research laboratory/clinical facility. The order of lens wear (intervention/control) will be randomized. The intervention and control lenses will be worn on different days with at least one day without contact lens wear separating the two measurement sessions.

Sponsors

Capricornia Contact Lenses
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

- Age 18- under 40 years - At least 0.00 logMAR visual acuity in each eye - No significant ocular disease - No significant eye movement anomalies

Exclusion criteria

- Any systemic disease, allergies, immunosuppressive diseases, autoimmune diseases, COVID-19 - Use of systemic medications known to have a side effect in the eyes or vision - Current use of any ocular medication - Ocular disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026