Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues

Macular Degeneration Clinical Trial

— RTS1  

Official title:

Comparing Vision Tests Integrated Into a Virtual Reality Technology Against Its Currently Used Analogues

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714424
• Other study ID #: GCO 19-03280
• Status: Recruiting
• Start date: November 13, 2019
• Est. completion date: July 2023

Study information

• Verified date: June 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Margarita Labkovich, BS
• Phone: (929) 464-6970
• Email: VReyecare[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Virtual reality (VR) constructs a 3-D reality right in a headset and the researchers are studying with what degree of accuracy it can be use to recreate vision tests that are used by eye doctors to screen and diagnose patients. VR provides advantages that could be used to improve eye care once the technology is tested and compared to the currently used vision tests - such as limiting the costs, duration and tedium associated with existing forms of vision screening tests. By doing so, the researchers hope to expand access to eye care by lowering the cost burden associated with vision tests. In this study, the research team will have subjects go through the VR versions of the test that are used in practice, and analyze their results in comparison to one another. After informed consent is obtained, the research team will collect subject demographic information (date of birth, gender, ethnicity, race) and clinically relevant medical history. Afterward, the research team will proceed to the virtual reality tests: vision field perimetry, Amsler, Snellen chart, contrast- sensitivity and currently used office tests. The participants will undergo all the tests, VR and non-VR, which will be delivered in a randomized order. The entire sequence will last 30 minutes to one hour for a single test. The VR component will last about 5 minutes, this being the only addition to the scheduled vision tests. The sequence of VR / non VR testing will be randomized. Based on the previous studies that compared Humphrey MATRIX visual field and Swedish Interactive algorithm, the effect size is determined to be at least 30 subjects, and the goal is to reach N=1,000 participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Ametropia
• Macular Degeneration
• Ptosis
• Refractive Errors

Intervention

Device:
• Virtual Reality Headset
Virtual reality (VR) - a 3-D reality right in a headset

Locations

Country	Name	City	State
United States	New York Eye & Ear Infirmary of Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

Beard C. Müller's superior tarsal muscle: anatomy, physiology, and clinical significance. Ann Plast Surg. 1985 Apr;14(4):324-33. — View Citation

Collin JR, Beard C, Wood I. Experimental and clinical data on the insertion of the levator palpebrae superioris muscle. Am J Ophthalmol. 1978 Jun;85(6):792-801. — View Citation

Cosh S, Carrière I, Daien V, Tzourio C, Delcourt C, Helmer C. Sensory loss and suicide ideation in older adults: findings from the Three-City cohort study. Int Psychogeriatr. 2019 Jan;31(1):139-145. doi: 10.1017/S104161021800056X. Epub 2018 May 25. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. eCollection 2016 Jul. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vision Field Perimetry	Vision field perimetry will me measured using Humphrey Vision Field Analyzer and a VR equivalent software.	Day 1
Primary	Acuity	Acuity will be measured using Tumbling E and LogMAR tests and a VR version of those tests.	Day 1
Primary	Contrast	Contrast sensitivity will be measured using the Pelli-Robson test and a VR version of the test.	Day 1
Primary	Color vision	Color vision will be measured by Ishihara plates and a VR version of the test.	Day 1
Secondary	Patient Satisfaction Survey	The survey consists of Likert scale questions to understand the patient's experience with the VR and analogues. The scale is evaluated from 1 to 5, with 1 meaning "very poor" and 5 meaning "very good". Score for each section (HVFA and VR) is 3 to 15. Total scale is 6 to 30, with higher score indicating more satisfaction.	Day 1