CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Intraocular pressureother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04308941
NCT04308941N/ACompleted

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

Boston Sight·interventional·Posted Mar 16, 2020·Updated Nov 9, 2023

In Brief

A clinical study evaluating Intraocular pressure for Intraocular Pressure and PROSE Lens. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 16, 2020
Enrollment StartApr 13, 2020
Primary CompletionApr 27, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.3 years ago

Interventions

Intraocular pressureother

The intraocular pressure will be measured using one of three devices