## Protocol Section
### Identification Module
**NCT ID:** NCT06428435

**Acronym:** NGHVA

**Brief Title:** Next Generation Home Vision Assessment

**Official Title:** Next Generation Home Vision Assessment

#### Organization Study ID Info
**ID:** 1.5
#### Organization
**Class:** OTHER_GOV
**Full Name:** NHS Forth Valley
#### Secondary ID Infos
**Domain:** IRAS Project ID
**ID:** 286078
**Type:** OTHER
**Domain:** REC Number
**ID:** 20/WM/0285
**Type:** OTHER
**Domain:** Edge ID
**ID:** 136640
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** NHS Greater Glasgow and Clyde

**Class:** OTHER

**Name:** Birmingham Children's Hospital

**Class:** OTHER_GOV

**Name:** NHS Fife

**Class:** OTHER

**Name:** NHS Highland

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** NHS Forth Valley

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 (e.g., 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.

### Conditions Module

**Conditions:**

- Amblyopia

- Vision; Low, One Eye (Other Eye Normal)

- Pediatric Disorder

**Keywords:**

- teleophthalmology

- remote consultations

- amblyopia

- paediatrics

- telemedicine

- digital health

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 360

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Tested with Ibis technology

**Intervention Names:**

- Diagnostic Test: Vision Test

**Label:** Ibis

#### Arm Group 2

**Description:** Tested with Optonet Technology

**Intervention Names:**

- Diagnostic Test: Vision Test

**Label:** Optonet

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ibis

- Optonet

**Description:** Remote vision testing via digital screen

**Name:** Vision Test

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Home versus Remote Acuity difference

**Measure:** Acuity

**Time Frame:** 2 weeks

#### Secondary Outcomes

**Description:** Digital versus in clinic standard

**Measure:** Colour Vision

**Time Frame:** 2 weeks

**Description:** Digital versus in clinic standard

**Measure:** Visual field

**Time Frame:** 2 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria

- Patients attending hospital eye services will be eligible for enrolment.

Age: less than 90 years old English speakers, as no available resource for translation services. Parents / patients must be able to provide consent Patient must be able to communicate what he / she sees on a vision assessment chart.

Must have access to smartphone, tablet or home computer that can run video conferencing platforms.

Exclusion criteria

Non English speakers or lack of ability to consent Inability to communicate what is seen on a chart, or inability to complete a preferential looking visual acuity test Inability to connect to a video conferencing platform.

**Maximum Age:** 90 Years

**Minimum Age:** 0 Months

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients attending hospital and at home

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Falkirk

**Country:** United Kingdom

**Facility:** NHS Forth Valley Research & Development Office

**State:** Stirlingshire

**Zip:** FK1 5SU

**Location 2:**

**City:** Birmingham

**Country:** United Kingdom

**Facility:** Birmingham Womens and Childens Hospital

**Zip:** B4 6NH

**Location 3:**

**City:** Glasgow

**Country:** United Kingdom

**Facility:** NHS Greater Glasgow & Clyde

**Location 4:**

**City:** Inverness

**Country:** United Kingdom

**Facility:** NHS Fife

**Zip:** IV2 3JH

#### Overall Officials

**Official 1:**

**Affiliation:** NHS Forth Valley

**Name:** Iain Livingstone, MBChB MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Open Access

**Description:** Anonymised data will be made available as part of publication

**IPD Sharing:** YES

**Time Frame:** Aim: 12 months post completion of study

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014786

- Term: Vision Disorders

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3891

- Name: Amblyopia

- Relevance: HIGH

- As Found: Amblyopia

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17530

- Name: Vision Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000550

- Term: Amblyopia

### Misc Info Module

- Version Holder: 2024-05-31
