Assessment of Visual Function in Ophthalmic Disorders Using Virtual Visual Field Analysis

NCT04110015 | Terminated DMC

• 1 other identifier: 2019-10418
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the accuracy of virtual visual field (VVF) headsets equipped the standard visual field software in its ability to assess visual function in various retinal, glaucoma and neuro-ophthalmic disorders by comparing retinal fundus and optic nerve images, optical coherence tomography and neuroimages to the VVF produced.
2. 2.To test the null hypothesis that VVF testing compares favorably to the gold standard, Humphrey visual field (HVF) by comparing testing time, mean sensitivity, markers of reliability including false positives and negatives and fixation losses and global indices such as mean deviation and pattern standard deviation.

Conditions

Visual Pathway Disorder; Glaucoma; Retinal Disease

Outcome Measures

Primary Outcomes (2)

• Virtual visual field result

  Gray scale pattern will reveal areas of vision loss or visual depression; this will have a numerical total deviation plot giving numbers in decibels of the points in the visual field of depressed or lost points of vision. Global indices also will be recorded; these give numerical quantification in decibel units of visual field loss. and include: mean deviation - the average of all decreased perception, pattern deviation which highlights localized losses and pattern standard deviation which quantifies the amount of loss and gauges progression. Time take to complete fields and reliability indices will be recorded: fixation losses, false positives, false negatives

  with 3 months

• Humphrey visual field result

  Gray scale pattern will reveal areas of vision loss or visual depression; this will have a numerical total deviation plot giving numbers in decibels of the points in the visual field of depressed or lost points of vision. Global indices also will be recorded; these give numerical quantification in decibel units of visual field loss. and include: mean deviation - the average of all decreased perception, pattern deviation which highlights localized losses and pattern standard deviation which quantifies the amount of loss and gauges progression.

  within 3 months

Secondary Outcomes (1)

• Comparison of Virtual Visual field (VVF) to Humphrey visual fields (HVF)

  At end of study when we have all the data ~ one year

Study Arms (3)

Neurology patients

Any patients with neurological disorders

Device: virtual visual field

Glaucoma patients

Any patients with chronic open angle and chronic angle closure glaucoma of all stages

Device: virtual visual field

Retina patients

Any patients with known retinal conditions

Device: virtual visual field

Interventions

virtual visual field DEVICE

Patients with identified conditions will be invited to do a virtual visual field test with virtual reality headsets.

Glaucoma patients; Neurology patients; Retina patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients (\>18yrs old) with glaucoma, retinal or neurological disorders able to understand, consent and deemed physically able to perform the visual field tests.

You may qualify if:

• Patients with retina, glaucoma and neuroophthalmic disorders
• Patients with normal eye exams to act as controls
• Must be able to comprehend instructions and perform visual fields

You may not qualify if:

• Patients \<18years old
• Patients unable to comprehend visual field instructions or unwilling to participate
• Patients lacking a complete clinical file or lacking a specific diagnosis

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Glaucoma; Retinal Diseases

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• JOYCE MBEKEANI

  Albert Einstein College of Medicine

  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 Ophthalmology & Visual Sciences

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: October 1, 2019
• Study Start: October 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: August 23, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)