Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428435
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-24
First Post:
2024-05-20
Brief Title:
Next Generation Home Vision Assessment
Sponsor:
NHS Forth Valley
Organization:
NHS Forth Valley
Study Overview
Official Title:
Next Generation Home Vision Assessment
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
NGHVA
Brief Summary:
Comparison of live remote paediatric digital vision testing outcomes versus face to face appointments in orthoptic clinic
Detailed Description:
Study Overview The Next Generation Home Vision Assessment study aims to evaluate the feasibility and accuracy of conducting vision assessments at home using a web-based platform This prospective non-interventional multi-center study will compare home-based vision tests with traditional hospital-based assessments
Study Background The COVID-19 pandemic has significantly limited patients ability to attend in-person eye clinic appointments impacting vision assessments and management Ramifications in delays continue to have an impact
Study Rationale This study seeks to validate home-based vision assessments against standard in-person evaluations to ensure patients can be effectively monitored and managed remotely The use of a web-based platform for vision tests could offer a reliable alternative reducing hospital visits and maintaining care standards
Objectives and Endpoints Primary Objective To compare the accuracy of home-based visual acuity tests to hospital-based assessments
Secondary Objectives To evaluate other aspects of visual function eg visual fields color vision contrast sensitivity and measure patient engagement and test duration
Study Design Type Prospective non-interventional Participants Adults and children attending hospital eye services Sample Size 360 completed assessments Duration Minimum of 6 months
Study Procedure Participants attending hospital eye services will be recruited and provided with a patient information leaflet Those willing to participate will undergo a visual acuity test - additional vision tests secondary outcomes during a video consultation Hospital-based assessment results will be compared to home-based test results to determine accuracy
Study Background The COVID-19 pandemic has significantly limited patients ability to attend in-person eye clinic appointments impacting vision assessments and management Ramifications in delays continue to have an impact
Study Rationale This study seeks to validate home-based vision assessments against standard in-person evaluations to ensure patients can be effectively monitored and managed remotely The use of a web-based platform for vision tests could offer a reliable alternative reducing hospital visits and maintaining care standards
Objectives and Endpoints Primary Objective To compare the accuracy of home-based visual acuity tests to hospital-based assessments
Secondary Objectives To evaluate other aspects of visual function eg visual fields color vision contrast sensitivity and measure patient engagement and test duration
Study Design Type Prospective non-interventional Participants Adults and children attending hospital eye services Sample Size 360 completed assessments Duration Minimum of 6 months
Study Procedure Participants attending hospital eye services will be recruited and provided with a patient information leaflet Those willing to participate will undergo a visual acuity test - additional vision tests secondary outcomes during a video consultation Hospital-based assessment results will be compared to home-based test results to determine accuracy
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 286078 | OTHER | None | None |
| 20WM0285 | OTHER | None | None |
| 136640 | OTHER | Edge ID | None |