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Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study

NCT04308941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-11-09

Study results available
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Summary

The goal of this research is to determine the reproducibility of measurements of intraocular pressure (IOP) when a scleral lens is on the eye. The PROSE device (PD) is a specialized scleral lens that is filled with preservative-free saline and then applied to the eye in order to treat a variety of ocular conditions. The fit of the PROSE device is optimized to land gently on the conjunctival tissue overlying the sclera while completely vaulting the cornea and limbus without touch.

Because the PROSE device vaults and therefore covers the cornea, measuring IOP during PROSE wear is challenging as traditional techniques rely on corneal contact (i.e. Goldmann tonometry, iCare, pneumatonometry, etc.). Measuring IOP before insertion and after removal of the PROSE device likely does not correspond to the true IOP when the PROSE device is actively on the eye.

This is a prospective study of the reproducibility of three non-traditional means of IOP measurements: scleral tonopen, scleral pneumatonometry, and transpalpebral Diaton tonometer. Evaluating these means of measurements may be important for future studies investigating the effect of PROSE wear on intraocular pressure.

Conditions

  • Intraocular Pressure and PROSE Lens

Interventions

DIAGNOSTIC_TEST

Intraocular pressure

The intraocular pressure will be measured using one of three devices

Sponsors & Collaborators

  • Boston Sight

    lead OTHER

Principal Investigators

  • Daniel Brocks, MD · Boston Sight

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-13
Primary Completion
2021-04-27
Completion
2021-04-27
FDA Device
Yes

Countries

  • United States

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 NCT04308941 on ClinicalTrials.gov