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

The effect of scleral contact lens fenestrations on tear exchange in adults with healthy corneas

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001164785
Enrollment
20
Registered
2022-08-24
Start date
2023-03-07
Completion date
2023-08-31
Last updated
2023-11-20

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 perforations to scleral contact lenses upon; 1) corneal tissue swelling, 2) tear flow behind the contact lens, and 3) build up of debris behind the contact lens in young healthy adults during short-term lens wear (3.5 hours). The null hypothesis is that the incorporation of scleral lens perforations will have no significant effect upon the primary outcome measures (1,2,3 listed above).

Interventions

The intervention is a highly oxygen permeable scleral contact lens with mid-peripheral fenestrations. All lenses will be fitted to each individual eye and assessed by a contact lens practitioner with over 10 years experience. The fenestrated scleral lenses will be worn in both eyes for one 4 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

The intervention is a highly oxygen permeable scleral contact lens with mid-peripheral fenestrations. All lenses will be fitted to each individual eye and assessed by a contact lens practitioner with over 10 years experience. The fenestrated scleral lenses will be worn in both eyes for one 4 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

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Healthy adults aged over 18 years in good general health with normal visual acuity in each eye. No contraindications to contact lens wear No history or evidence of any ocular disease, injury, or surgery Willing to refrain from soft contact lens wear for at least 24 hours prior to each study visit Able to be fitted with scleral contact lenses required for the study

Exclusion criteria

History of eye disease, surgery, or injury Contraindications to contact lens wear Systemic disease (e.g. diabetes) or use of systemic medications (e.g. medications that affect the tear film) Regular rigid contact lens wear Unable to achieve a satisfactory lens fit with the study scleral contact lenses Known allergy to sodium fluorescein or contact lens solutions

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026