Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-30 @ 10:48 PM
Study NCT ID:
NCT06883032
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2025-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Accuracy of an Automated Refractor to Provide Well-tolerated Eyeglass Prescriptions
Sponsor:
PlenOptika, Inc.
Organization:
Study Overview
Official Title:
Validation of the QuickSee Plus Device
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At the New England College of Optometry in Boston, MA, subjects ages 18-65 who have received or are receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and automated refraction, by way of the QuickSee Plus refractor. Subjects will then be randomized into one of two treatment plans: receive glasses from automated refraction first then subjective refraction second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a triple blind, case-crossover clinical trial.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2R44EY025452-04 | NIH | None | https://reporter.nih.gov/quic… | View |