PtosisRTS1NCT04714424
Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues
An observational study of Ptosis and Macular Degeneration, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ptosis, Macular Degeneration, Ametropia
- What is being tested?
- Virtual Reality Headset
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to 24 Oct 2022
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from New York Eye and Ear Infirmary.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Eye & Ear Infirmary of Mount Sinai
New York, New York, 10003
About this study
Official title: Comparing Vision Tests Integrated Into a Virtual Reality Technology Against Its Currently Used Analogues
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.
Read the detailed 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.
- Conditions
- Ptosis, Macular Degeneration, Ametropia
- Being tested
- Virtual Reality Headset
- Keywords
- Vision screening, Virtual reality, Field test, Visual acuity, Contrast sensitivity
- Medical subject headings
- Blepharoptosis, Macular Degeneration, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
Also called Vive Pro
Virtual reality (VR) - a 3-D reality right in a headset
| Study group | Role | What they receive |
|---|---|---|
| Participants undergoing vision exams | Not described Receives: Device: Virtual Reality Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision Field Perimetry
Vision field perimetry will me measured using Humphrey Vision Field Analyzer and a VR equivalent software.
Measured: Day 1
Acuity
Acuity will be measured using Tumbling E and LogMAR tests and a VR version of those tests.
Measured: Day 1
Contrast
Contrast sensitivity will be measured using the Pelli-Robson test and a VR version of the test.
Measured: Day 1
Color vision
Color vision will be measured by Ishihara plates and a VR version of the test.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start13 Jan 2020
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for PtosisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Chelnis, Icahn School of Medicine at Mount Sinai
- Investigators
- James Chelnis, MD, Principal investigator, New York Eye and Ear Infirmary of Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714424
- Sponsor's protocol ID
- GCO 19-03280
- Acronym
- RTS1
- Status last verified
- Aug 2024
- First submitted
- 14 Jan 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
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.
PubMed 30336129Kimura 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.
PubMed 30936681Lowry 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.
PubMed 27486554Phu 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.
PubMed 28640951Prema 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.
PubMed 19384015Scarfe 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.
PubMed 26161632Sharma 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.
PubMed 10708227Barbour 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.
PubMed 28278145Beard 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.
PubMed 3994278Collin 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.
PubMed 98045Cosh 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.
PubMed 29798742DeBuc 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.
PubMed 27841014Lee 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.
PubMed 27633646Goh 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.
PubMed 29372112Hootman 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.
PubMed 27015600
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Vision Tests Integrated Into a Virtual Reality Technology Against Its Currently Used Analogues
- ClinicalTrials.gov ID
- NCT04714424
- Acronym / sponsor ID
- RTS1 / GCO 19-03280
- Conditions
- Ptosis, Macular Degeneration, Ametropia
- Keywords
- Vision screening, Virtual reality, Field test, Visual acuity, Contrast sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants undergoing vision exams | – | Device: Virtual Reality Headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from New York Eye and Ear Infirmary.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality HeadsetAlso: Vive ProVirtual reality (VR) - a 3-D reality right in a headset | Device | Participants undergoing vision exams |
Primary outcome
Vision Field Perimetry
Time frame: Day 1
Vision field perimetry will me measured using Humphrey Vision Field Analyzer and a VR equivalent software.
Acuity
Time frame: Day 1
Acuity will be measured using Tumbling E and LogMAR tests and a VR version of those tests.
Contrast
Time frame: Day 1
Contrast sensitivity will be measured using the Pelli-Robson test and a VR version of the test.
Color vision
Time frame: Day 1
Color vision will be measured by Ishihara plates and a VR version of the test.
1 secondary outcome
Patient Satisfaction Survey
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 30336129Heijl 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.
- Background: PubMed 30936681Kimura 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.
- Background: PubMed 27486554Lowry 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.
- Background: PubMed 28640951Phu 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.
- Background: PubMed 19384015Prema 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.
- Background: PubMed 26161632Scarfe 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.
- Background: PubMed 10708227Sharma 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.
- Background: PubMed 28278145Barbour 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.
- Background: PubMed 3994278Beard 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.
- Background: PubMed 98045Collin 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.
- Background: PubMed 29798742Cosh 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.
- Background: PubMed 27841014DeBuc 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Chelnis, MD principal investigator
New York Eye and Ear Infirmary of Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ptosis and Macular Degeneration, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision Field Perimetry (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04714424, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.