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Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study
NA trial testing Intraocular pressure in Intraocular Pressure and PROSE Lens in 30 participants. Completed in 27 April 2021.
| Lead sponsor | Boston Sight |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 30 |
| Start date | 13 April 2020 |
| Primary completion | 27 April 2021 |
| Estimated completion | 27 April 2021 |
| Sites | 1 location across United States |
Boston Sight
18 and older, any sex, with Intraocular Pressure and PROSE Lens. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Intraocular pressure will be measured using one of three different tonometers. The reproducibility of measurements on each device will be studied.
| Group | Value | 95% CI |
|---|---|---|
| Tonopen | 24.23 | ± 8.59 |
| Scleral Pneumotonometry | 22.32 | ± 6.41 |
| Diaton | 24.52 | ± 12.20 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing