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NCT04308941 · ClinicalTrials.gov registry record · NA
Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study
A NA study, sponsored by Boston Sight.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT04308941: Completed NA study, sponsored by Boston Sight.
NCT04308941 is a NA study that has completed, run by Boston Sight. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04308941, a NA study, has completed, sponsored by Boston Sight.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
Intraocular pressure will be measured using one of three different tonometers. The reproducibility of measurements on each device will be studied.
Interventions
- DIAGNOSTIC_TEST Intraocular pressure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-04-13 |
| Est. Completion | 2021-04-27 |
| Phase | NA |
What the finished NCT04308941 record still lists
NCT04308941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Intraocular pressure is the first listed.
NCT04308941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04308941 about?
NCT04308941 is a clinical study titled "Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study". 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 o...
What is the current status of trial NCT04308941?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2020-04-13. Estimated completion is 2021-04-27.
What interventions are being tested in trial NCT04308941?
The interventions under investigation include: Intraocular pressure (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04308941?
This trial is sponsored by Boston Sight, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04308941's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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