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

NCT ID: NCT04994457

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

287 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-30

Study Completion Date

2024-06-21

Brief Summary

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

Detailed Description

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Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Virtual Reality Visual Field

Intervention Type DEVICE

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

Visual Field Naive Adults

Visual Field Naive Adults will receive SAP and VRVF

Virtual Reality Visual Field

Intervention Type DEVICE

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

Standard Automated Perimetry

Intervention Type DIAGNOSTIC_TEST

Standard of care perimeter

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

Virtual Reality Visual Field

Intervention Type DEVICE

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

Visual Field Naive Children

Visual Field Naive Children will receive SAP and VRVF

Virtual Reality Visual Field

Intervention Type DEVICE

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

Standard Automated Perimetry

Intervention Type DIAGNOSTIC_TEST

Standard of care perimeter

Remote Care Arm

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

Virtual Reality Visual Field

Intervention Type DEVICE

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

Ptosis Arm

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

Virtual Reality Visual Field

Intervention Type DEVICE

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

Standard Automated Perimetry

Intervention Type DIAGNOSTIC_TEST

Standard of care perimeter

Interventions

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Virtual Reality Visual Field

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

Intervention Type DEVICE

Standard Automated Perimetry

Standard of care perimeter

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion:

* 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
Minimum Eligible Age

1 Year

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Elena Bitrian

Associate Professor of Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elena Bitrian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Bascom Palmer Eye Institute

Miami, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37647317 (View on PubMed)

Other Identifiers

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20210472

Identifier Type: -

Identifier Source: org_study_id

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