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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants undergoing vision exams |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Headset | Device | Virtual reality (VR) - a 3-D reality right in a headset |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from New York Eye and Ear Infirmary.
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| Name | Affiliation | Role |
|---|---|---|
| James Chelnis, MD | New York Eye and Ear Infirmary of Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Eye & Ear Infirmary of Mount Sinai | New York | New York | 10003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30336129 | Background | 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. | |
| 30936681 | 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. |
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All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
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.
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| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| D008268 | Macular Degeneration |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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| 27486554 | 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. |
| 28640951 | 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. |
| 19384015 | 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. |
| 26161632 | 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. |
| 10708227 | 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. |
| 28278145 | 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. |
| 3994278 | Background | Beard C. Muller's superior tarsal muscle: anatomy, physiology, and clinical significance. Ann Plast Surg. 1985 Apr;14(4):324-33. doi: 10.1097/00000637-198504000-00005. |
| 98045 | Background | 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. doi: 10.1016/s0002-9394(14)78107-3. |
| 29798742 | Background | Cosh S, Carriere 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. |
| 27841014 | Background | 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. |
| 27633646 | Background | 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. |
| 29372112 | 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. |
| 27015600 | Background | 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. |
| 38408310 | Derived | 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. |