Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care

NCT04994457 | Completed FDA Device

• 1 other identifier: 20210472
• Study Type: observational
• Target: 287
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.

Conditions

Glaucoma

Keywords

Visual Field; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• Sensitivity of VRVF compared to SAP

  Sensitivity of VRVF will be determined by comparing Hodapp Anderson Parrish (HAP) Scores, which assess the severity of visual field defects, to those of SAP

  Day 1

• Specificity of VRVF compared to SAP

  Specificity of VRVF will be determined by comparing Hodapp Anderson Parrish (HAP) Scores, which assess the severity of visual field defects, to those of SAP

  Day 1

Secondary Outcomes (1)

• Variability of Mean Deviation

  Day 1

Study Arms (6)

Adults with Glaucoma or Suspected Glaucoma

Adults with Glaucoma or Suspected Glaucoma, who have previously had standard automated perimetry (SAP) and will receive virtual reality visual field (VRVF) as part of the standard of care

Device: Virtual Reality Visual Field

Visual Field Naive Adults

Visual Field Naive Adults will receive SAP and VRVF

Device: Virtual Reality Visual Field; Diagnostic Test: Standard Automated Perimetry

Children with Glaucoma or Suspected Glaucoma

Children with Glaucoma or Suspected Glaucoma, who have previously had SAP and will receive VRVF as part of the standard of care

Device: Virtual Reality Visual Field

Visual Field Naive Children

Visual Field Naive Children will receive SAP and VRVF

Device: Virtual Reality Visual Field; Diagnostic Test: Standard Automated Perimetry

Remote Care Arm

Glaucoma or Suspected Glaucoma participants, who have previously had SAP and will receive VRVF at their home

Device: Virtual Reality Visual Field

Ptosis Arm

Patients diagnosed with Ptosis, brow ptosis, or dermatochalasis, will receive a specialized version of VRVF and SAP, specifically to detect ptosis

Device: Virtual Reality Visual Field; Diagnostic Test: Standard Automated Perimetry

Interventions

Virtual Reality Visual Field DEVICE

A head-mounted perimeter with a wireless remote connected to a laptop that monitors responses

Adults with Glaucoma or Suspected Glaucoma; Children with Glaucoma or Suspected Glaucoma; Ptosis Arm; Remote Care Arm; Visual Field Naive Adults; Visual Field Naive Children

Standard Automated Perimetry DIAGNOSTIC_TEST

Standard of care perimeter

Ptosis Arm; Visual Field Naive Adults; Visual Field Naive Children

Eligibility Criteria

• Age: 1 Year - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are glaucoma or glaucoma suspect who are being seen at Bascom Palmer Eye Institute and/or healthy individuals

You may qualify if:

• Any individual who is physically able to take a virtual reality visual field test
• Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma, or have other visual field defects, and normal individual
• Age: Individuals who are old enough to comprehend the instructions and procedures (1-90)

You may not qualify if:

• Adults unable to consent, prisoners
• Participants who are too tired to take a visual field test
• Participants who refuse to consent
• Individuals who are functionally unable to use VRVF

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Related Publications (1)

• McLaughlin DE, Savatovsky EJ, O'Brien RC, Vanner EA, Munshi HK, Pham AH, Grajewski AL. Reliability of Visual Field Testing in a Telehealth Setting Using a Head-Mounted Device: A Pilot Study. J Glaucoma. 2024 Jan 1;33(1):15-23. doi: 10.1097/IJG.0000000000002290. Epub 2023 Aug 14.

  PMID: 37647317 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Elena Bitrian, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: October 30, 2021
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)