CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Ocular surface optical coherence tomographydevice
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/NCT04649177
NCT04649177N/ACompleted

Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting

Boston Sight·interventional·Posted Dec 2, 2020·Updated Oct 27, 2023

In Brief

A clinical study evaluating Ocular surface optical coherence tomography for Keratoconus and 8 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 2, 2020
Enrollment StartDec 15, 2020
Primary CompletionMar 23, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.6 years ago

Interventions

Ocular surface optical coherence tomographydevice

EYEdeal Scanning technology enables rapid measurement of the corneal and scleral topography which provides data for an automated sequence to fit PROSE devices