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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 is a NA study that has completed, run by Boston Sight. The registered enrollment target is 11 participants.

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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.

Interventions

  • DEVICE Ocular surface optical coherence tomography

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2020-12-15
Est. Completion 2022-03-23
Phase NA

Sponsor

Boston Sight

4 total trials

What the Registry Record Tells You About NCT04649177

The ClinicalTrials.gov registry entry for NCT04649177 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Sight, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Ocular surface optical coherence tomography is the first listed.

NCT04649177 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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