Ignite Creation Date:
2025-12-18 @ 9:56 AM
Ignite Modification Date:
2025-12-23 @ 5:49 PM
Study NCT ID:
NCT05030714
Status:
None
Last Update Posted:
2023-02-21 00:00:00
First Post:
2021-08-23 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
Sponsor:
None
Organization:
Study Overview
Official Title:
Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
Status:
None
Status Verified Date:
2023-02
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:
This proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. The novel head-mounted device, with custom software, will be compared to a conventional visual field test: The Humphrey Visual Field Analyzer. The investigators will include 30 healthy normal patients, 30 glaucoma suspects, 30 patients with moderate glaucoma, and 30 patients with advanced glaucoma (total: 120 patients). Each patient will perform the conventional test and the head-mounted device visual field test during the study visit, with the order (i.e., which device the patient starts with) being randomized. After the two tests, the patient will fill out a questionnaire to gather information regarding patient comfort and satisfaction. This will repeat each week for 5 weeks, for a total of 5 study visits. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and head-mounted device will be similar.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: