Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues

NCT04714424 | Completed DMC FDA Device

• 1 other identifier: GCO 19-03280
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the results of vision tests that are algorithmically derived and delivered through a virtual reality headset with those delivered through the existing technology standards (eg. Humphrey for field tests). Tests that the researchers will be conducting include vision field perimetry, Amsler, acuity chart, contrast- sensitivity and currently used office tests.

Conditions

Ptosis; Macular Degeneration; Ametropia

Keywords

Vision screening; Virtual reality; Field test; Visual acuity; Contrast sensitivity

Outcome Measures

Primary Outcomes (4)

• Vision Field Perimetry

  Vision field perimetry will me measured using Humphrey Vision Field Analyzer and a VR equivalent software.

  Day 1

• Acuity

  Acuity will be measured using Tumbling E and LogMAR tests and a VR version of those tests.

  Day 1

• Contrast

  Contrast sensitivity will be measured using the Pelli-Robson test and a VR version of the test.

  Day 1

• Color vision

  Color vision will be measured by Ishihara plates and a VR version of the test.

  Day 1

Secondary Outcomes (1)

• Patient Satisfaction Survey

  Day 1

Study Arms (1)

Participants undergoing vision exams

Device: Virtual Reality Headset

Interventions

Virtual Reality Headset DEVICE

Virtual reality (VR) - a 3-D reality right in a headset

Also known as: Vive Pro

Participants undergoing vision exams

Eligibility Criteria

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

Study Population

Patients will be recruited from New York Eye and Ear Infirmary.

You may qualify if:

• Male and female patients of any race who are at least 18 years of age and can understand and provide verbal and written informed consent are eligible for this study.

You may not qualify if:

• Patients who have had intraocular surgery less than six months ago,
• Potential contraindication for visual field test that include anxiety disorder, pregnancy, seizure disorder,cardiac pacemaker or another implantable device, severe vertigo or balance issues.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

New York Eye & Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

Location

Related Publications (16)

• Heijl A, Patella VM, Chong LX, Iwase A, Leung CK, Tuulonen A, Lee GC, Callan T, Bengtsson B. A New SITA Perimetric Threshold Testing Algorithm: Construction and a Multicenter Clinical Study. Am J Ophthalmol. 2019 Feb;198:154-165. doi: 10.1016/j.ajo.2018.10.010. Epub 2018 Oct 16.

  PMID: 30336129 BACKGROUND

• Kimura T, Matsumoto C, Nomoto H. Comparison of head-mounted perimeter (imo(R)) and Humphrey Field Analyzer. Clin Ophthalmol. 2019 Mar 14;13:501-513. doi: 10.2147/OPTH.S190995. eCollection 2019.

  PMID: 30936681 BACKGROUND

• Lowry EA, Hou J, Hennein L, Chang RT, Lin S, Keenan J, Wang SK, Ianchulev S, Pasquale LR, Han Y. Comparison of Peristat Online Perimetry with the Humphrey Perimetry in a Clinic-Based Setting. Transl Vis Sci Technol. 2016 Jul 19;5(4):4. doi: 10.1167/tvst.5.4.4. eCollection 2016 Jul.

  PMID: 27486554 BACKGROUND

• Phu J, Khuu SK, Yapp M, Assaad N, Hennessy MP, Kalloniatis M. The value of visual field testing in the era of advanced imaging: clinical and psychophysical perspectives. Clin Exp Optom. 2017 Jul;100(4):313-332. doi: 10.1111/cxo.12551. Epub 2017 Jun 22.

  PMID: 28640951 BACKGROUND

• Prema R, George R, Hemamalini A, Sathyamangalam Ve R, Baskaran M, Vijaya L. Comparison of Humphrey MATRIX and Swedish interactive threshold algorithm standard strategy in detecting early glaucomatous visual field loss. Indian J Ophthalmol. 2009 May-Jun;57(3):207-11. doi: 10.4103/0301-4738.49395.

  PMID: 19384015 BACKGROUND

• Scarfe P, Glennerster A. Using high-fidelity virtual reality to study perception in freely moving observers. J Vis. 2015;15(9):3. doi: 10.1167/15.9.3.

  PMID: 26161632 BACKGROUND

• Sharma AK, Goldberg I, Graham SL, Mohsin M. Comparison of the Humphrey swedish interactive thresholding algorithm (SITA) and full threshold strategies. J Glaucoma. 2000 Feb;9(1):20-7. doi: 10.1097/00061198-200002000-00005.

  PMID: 10708227 BACKGROUND

• Barbour KE, Helmick CG, Boring M, Brady TJ. Vital Signs: Prevalence of Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation - United States, 2013-2015. MMWR Morb Mortal Wkly Rep. 2017 Mar 10;66(9):246-253. doi: 10.15585/mmwr.mm6609e1.

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• DeBuc DC. The Role of Retinal Imaging and Portable Screening Devices in Tele-ophthalmology Applications for Diabetic Retinopathy Management. Curr Diab Rep. 2016 Dec;16(12):132. doi: 10.1007/s11892-016-0827-2.

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• Lee CS, Morris A, Van Gelder RN, Lee AY. Evaluating Access to Eye Care in the Contiguous United States by Calculated Driving Time in the United States Medicare Population. Ophthalmology. 2016 Dec;123(12):2456-2461. doi: 10.1016/j.ophtha.2016.08.015. Epub 2016 Sep 12.

  PMID: 27633646 BACKGROUND

• Goh RLZ, Kong YXG, McAlinden C, Liu J, Crowston JG, Skalicky SE. Objective Assessment of Activity Limitation in Glaucoma with Smartphone Virtual Reality Goggles: A Pilot Study. Transl Vis Sci Technol. 2018 Jan 23;7(1):10. doi: 10.1167/tvst.7.1.10. eCollection 2018 Jan.

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• Hootman JM, Helmick CG, Barbour KE, Theis KA, Boring MA. Updated Projected Prevalence of Self-Reported Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation Among US Adults, 2015-2040. Arthritis Rheumatol. 2016 Jul;68(7):1582-7. doi: 10.1002/art.39692.

  PMID: 27015600 BACKGROUND

• Cheng CP, Serafini RA, Labkovich M, Warburton AJ, Navarro V, Shaik N, Reddy H, Chelnis JG. Clinical report: Virtual reality enables comparable contrast sensitivity measurements to in-office testing (pilot study). Optom Vis Sci. 2024 Feb 1;101(2):124-128. doi: 10.1097/OPX.0000000000002107. Epub 2024 Jan 16.

  PMID: 38408310 DERIVED

MeSH Terms

Conditions

Blepharoptosis; Macular Degeneration; Refractive Errors

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases

Study Officials

• James Chelnis, MD

  New York Eye and Ear Infirmary of Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor, MD

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: January 13, 2020
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Data available on specific request and will be shared securely as CSV.

Locations

US (1)