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NCT04649177 · ClinicalTrials.gov registry record · NA
Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting
A NA study, sponsored by Boston Sight.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT04649177: Completed NA study, sponsored by Boston Sight.
NCT04649177 is a NA study that has completed, run by Boston Sight. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04649177, a NA study, has completed, sponsored by Boston Sight.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
EYEdeal Scanning Technology enables rapid measurement of corneal and scleral topography. By accurately measuring the ocular surface with this imaging technology, the current iterative fitting method required to fit PROSE (prosthetic replacement of the ocular surface ecosystem) devices could be replaced and/or strengthened with a more rapid, automated fitting sequence. This could considerably reduce the time needed per visit, the number of visits, and the number of devices needed to be manufactured to reach the endpoint. Additionally, the scanning technology may afford the opportunity to successfully fit some pathology that were previously treatment failures. The automated technology may as well reduce the intensive clinician training time needed to fit PROSE devices, therefore increasing the availability and access to patients. The goal of this research is to evaluate the reliability and efficacy of this automated technology for fitting PROSE devices. Data from real-time measurement of the human eye ocular surface topography will be used to fabricate a prosthetic lens. The fit of the PROSE device will be evaluated, as well as the subjective comfort of the fit.
Primary Outcome
Central corneal clearance as measured by OCT after 45 minutes of lens wear Outcome measure reports data only from the study eye.
Interventions
- DEVICE Ocular surface optical coherence tomography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-12-15 |
| Est. Completion | 2022-03-23 |
| Phase | NA |
What the finished NCT04649177 record still lists
NCT04649177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Ocular surface optical coherence tomography is the first listed.
NCT04649177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04649177 about?
NCT04649177 is a clinical study titled "Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting". EYEdeal Scanning Technology enables rapid measurement of corneal and scleral topography. By accurately measuring the ocular surface with this imaging technology, the current iterative fitting method required to fit PROSE (prosthetic replacement of the ocular surface ecosystem) devices could be repla...
What is the current status of trial NCT04649177?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2020-12-15. Estimated completion is 2022-03-23.
What interventions are being tested in trial NCT04649177?
The interventions under investigation include: Ocular surface optical coherence tomography (DEVICE).
Who is sponsoring clinical trial NCT04649177?
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 NCT04649177's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 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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