Low VisioneLVESNCT03728660
Design and Clinical Evaluation of a Smartphone-based Low Vision Enhancement System
A study testing Virtual bioptic magnification with large field of view and Full field magnification with small field of view in people with Low Vision, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary objective is to compare the effectiveness and adverse side-effects of the virtual bioptic telescope and virtual projection screen in a new head-mounted video-based low vision enhancement system (LVES) with a wide field of view to currently employed specifications for head-mounted video display low vision… Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Low Vision
- What is being tested?
- Virtual bioptic magnification with large field of view and Full field magnification with small field of view
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 5 Feb 2021
- Phase
- Interventional
- 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 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Visual acuity in the better-seeing eye 20/60-20/800
- Horizontal visual field extent >70 degrees diameter, vertical visual field extent >50 degrees.
- Indicate at least 2 goals from the Activity Inventory during the initial screening interview.
- Scores at least 27 in the Telephone Interview Cognitive Status during the initial screening interview
Who cannot join
- Patients who are planning ocular surgery (including laser surgery) during the period of study participation or are early in anti-neovascular treatment (<6 injections)
- Younger than 14 years of age
- Unable to participate in a telephone interview
- Indicate less than 2 goals from the Activity Inventory
- Score less than 27 in the Telephone Interview Cognitive Status
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to compare the effectiveness and adverse side-effects of the virtual bioptic telescope and virtual projection screen in a new head-mounted video-based low vision enhancement system (LVES) with a wide field of view to currently employed specifications for head-mounted video display low vision enhancement technology. Secondary objectives are to acquire qualitative information from patients to evaluate the functioning of the system, to optimize system features and operations, and to assess the value patients place on system features, functions, and operating parameters relative to those of current technology. Investigators will conduct a comparative effectiveness study to determine if the novel vision enhancing features of LVES 2 provide low vision patients with benefits superior to those provided by existing technology.
Read the detailed description
The study will employ a single center, randomized crossover design with a 2-week trial period before the crossover, a 22-week washout period, and a 2-week trial period after the cross over. Once recruited patients have consented to participate in eligibility screening for the study, participants will be administered the Activity Inventory (AI), a rating scale questionnaire about the difficulty of performing a wide range of daily activities and the Telephone Interview for Cognitive Status (TICS) Eligible patients who consent to participate will be randomized to Group A or Group B. Group A will be trained to use and will employ at home for the first 2-week trial period, the headset with the new LVES 2 features and specifications and then, after the 22-week washout period, will be trained to use and employ at home for the second 2-week trial period the headset with currently available features and specifications ("legacy system"). The order will be reversed for Group B who will start with the legacy system for trial period 1 and then switch to the new LVES 2 system for trial period 2 after the 22-week washout.
Prior to each 2-week trial period, participants will visit the laboratory and will be taught how to operate the new LVES 2. Once the participant is familiar with the basic control operations, he/she will receive one on one instruction from a low vision rehabilitation therapist on the use of the device with the features and specifications to be tested to perform distance, intermediate and near activities. Prior to dispensing either device for a 2-week home trial evaluation, the patient must demonstrate to the satisfaction of the therapist a basic knowledge of and successful operational skill with the device, including an understanding that participants are not to attempt to walk or operate a vehicle while wearing the device.
Guided by the AI results, participants will be instructed on the types of activities participants should perform at home while using the device. The participant will also take part in baseline testing in 1. Facial recognition, 2.Visual motor test, 3. The International Reading Speed Texts (IReST) to assess reading performance, and 4. a modified Timed Activity of Daily Living (TIADL) performance test. The patient will be called during the 2-week home trial period and a Simulator Sickness Questionnaire (SSQ) will be administered. A follow-up AI will be administered at the end of the 2-week trial. The participant will return the headset to the laboratory after the 2-week trial and will be debriefed on participant's experiences and impressions. The 4 tests will be repeated at this visit (Facial recognition, Visual motor, IReST and TIADL). None of these procedures are part of or substitute for the patient's routine care. Investigators will employ rolling enrollment of participants on staggered schedules. Investigators expect to complete the 50th participant with the first condition in 22 weeks and then Investigators will start the crossover phase after the 22-week washout. Investigators expect to complete both phases with the first 50 patients (less drop outs) in year 1. Investigators then repeat the procedure with the next group of 50 participants in year 2, using systems that include new software features developed in response to participant feedback.
A treatment success is defined as an improvement in functional ability measured with the Activity Inventory that exceeds the 95% confidence interval of the estimated baseline measure [i.e.,Minimum Clinically Important Difference (MCID)]. Stopping the home trial will not be initiated by the investigators, but participants who are experiencing significant simulator sickness will be encouraged to stop.
Participants who stop the home trial prematurely will still be asked to complete the post-trial debriefing and the follow-up AI. Since study participation does not substitute for the patient's regular clinical care, there is no consequence to the patient for prematurely ending study participation.
- Conditions
- Low Vision
- Being tested
- Virtual bioptic magnification with large field of view, Full field magnification with small field of view
- Keywords
- age related macular degeneration, visual impairment, virtual reality
- Medical subject headings
- Vision, Low, Macular Degeneration, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual bioptic magnification with large field of viewDevice
Also called LVES 2, IrisVision
The intervention device will have a larger field of vision than the legacy device and the intervention device will also have a virtual bioptic telescope mode not found on the legacy device. The user will be able to adjust the size of the virtual bioptic telescope and the amount of magnification with a touch pad on the side of the head-mounted display (HMD).
Full field magnification with small field of viewDevice
Also called LEGACY
Comparison intervention with user-controlled full field magnification with a smaller field size shared by legacy head-mounted devices. User can control amount of magnification
| Study group | Role | What they receive |
|---|---|---|
| LVES 2 first LEGACY second | Experimental | Virtual bioptic magnification with large field of view (LVES 2) followed by 22-week washout period and then Full field magnification with small field of view (LEGACY) Receives: Device: Virtual bioptic magnification with large field of view; Device: Full field magnification with small field of view |
| LEGACY first LVES 2 second | Active comparator | Full field magnification with small field of view (LEGACY) followed by 22-week washout period and then Virtual bioptic magnification with large field of view (LVES 2) Receives: Device: Virtual bioptic magnification with large field of view; Device: Full field magnification with small field of view |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in patients' self-reported functional ability as assessed by the Activity Inventory (AI) rating scale questionnaire
Functional ability is estimated from difficulty ratings of items in the AI, a questionnaire that banks 510 items describing common activities. 50 items are "goals", broad descriptions of activity accomplishments. The other 460 items are "tasks", specific activities typically performed to achieve goals. The patient rates the importance of each goal. Unimportant goals are skipped, otherwise the patient rates the goal's difficulty. If "not difficult", the patient skips to the next goal, otherwise rates the difficulty of the goal's subsidiary tasks, or responds "not applicable". The average ability required by each item and the functional ability of each patient are estimated on the same scale with Rasch analysis. The 510 item measures in the AI are fixed to values for 3000 low vision patients. The investigators will analyze functional ability change score distributions for the two interventions before and after the crossover.
Measured: 2 weeks, 24 weeks
Secondary outcomes (1)
Minimum Clinically Important Difference (MCID) in patient's self-reported functional ability estimated from difficulty ratings of activities in the AI rating scale questionnaire
MCID is a clinical endpoint defined as a change (an improvement) in the person measure from pre-trial period to post-trial period estimated from all items in the Activity Inventory identified by the patient as relevant and at least somewhat difficult at baseline that exceeds that patient's 95% confidence interval for person measure change (see the Outcome 1 description for details). MCID counts are repeated for the crossover after a 22-week washout period. The investigators will compare the rates of achieving MCID endpoints for the two intervention arms both before and after the crossover.
Measured: 2 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start29 Jan 2019
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low VisionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intention to treat design; crossover with 22 week washout period between interventions; primary outcome measure is patient-reported function
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Visionize, LLC
- Responsible party
- Sponsor
- Investigators
- Robert W Massof, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728660
- Sponsor's protocol ID
- IRB00086366
- Other IDs
- 4R44EY028077-02
- Acronym
- eLVES
- Status last verified
- Dec 2020
- First submitted
- 31 Oct 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If individual participant data (IPD) is shared, it will be in the form of a csv data file included as supplemental material attached to the published results.
Publications
Deemer AD, Bradley CK, Ross NC, Natale DM, Itthipanichpong R, Werblin FS, Massof RW. Low Vision Enhancement with Head-mounted Video Display Systems: Are We There Yet? Optom Vis Sci. 2018 Sep;95(9):694-703. doi: 10.1097/OPX.0000000000001278.
PubMed 30153240Goldstein JE, Jackson ML, Fox SM, Deremeik JT, Massof RW; Low Vision Research Network Study Group. Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers. JAMA Ophthalmol. 2015 Jul;133(7):762-9. doi: 10.1001/jamaophthalmol.2015.0693.
PubMed 25856370Massof RW, Ahmadian L, Grover LL, Deremeik JT, Goldstein JE, Rainey C, Epstein C, Barnett GD. The Activity Inventory: an adaptive visual function questionnaire. Optom Vis Sci. 2007 Aug;84(8):763-74. doi: 10.1097/OPX.0b013e3181339efd.
PubMed 17700339Chun R, Deemer A, Fujiwara K, Deremeik J, Bradley CK, Massof RW, Werblin FS. Comparative effectiveness between two types of head-mounted magnification modes using a smartphone-based virtual display. Optom Vis Sci. 2024 Jun 1;101(6):342-350. doi: 10.1097/OPX.0000000000002115. Epub 2024 Apr 12.
PubMed 38551973
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Clinical Evaluation of a Smartphone-based Low Vision Enhancement System
- ClinicalTrials.gov ID
- NCT03728660
- Acronym / sponsor ID
- eLVES / IRB00086366
- Conditions
- Low Vision
- Keywords
- age related macular degeneration, visual impairment, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Visionize, LLC
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 2 Nov 2018 (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 primary objective is to compare the effectiveness and adverse side-effects of the virtual bioptic telescope and virtual projection screen in a new head-mounted video-based low vision enhancement system (LVES) with a wide field of view to currently employed specifications for head-mounted video display low vision enhancement technology. Secondary objectives are to acquire qualitative information from patients to evaluate the functioning of the system, to optimize system features and operations, and to assess the value patients place on system features, functions, and operating parameters relative to those of current technology. Investigators will conduct a comparative effectiveness study to determine if the novel vision enhancing features of LVES 2 provide low vision patients with benefits superior to those provided by existing technology.
Detailed description
The study will employ a single center, randomized crossover design with a 2-week trial period before the crossover, a 22-week washout period, and a 2-week trial period after the cross over. Once recruited patients have consented to participate in eligibility screening for the study, participants will be administered the Activity Inventory (AI), a rating scale questionnaire about the difficulty of performing a wide range of daily activities and the Telephone Interview for Cognitive Status (TICS) Eligible patients who consent to participate will be randomized to Group A or Group B. Group A will be trained to use and will employ at home for the first 2-week trial period, the headset with the new LVES 2 features and specifications and then, after the 22-week washout period, will be trained to use and employ at home for the second 2-week trial period the headset with currently available features and specifications ("legacy system"). The order will be reversed for Group B who will start with the legacy system for trial period 1 and then switch to the new LVES 2 system for trial period 2 after the 22-week washout.
Prior to each 2-week trial period, participants will visit the laboratory and will be taught how to operate the new LVES 2. Once the participant is familiar with the basic control operations, he/she will receive one on one instruction from a low vision rehabilitation therapist on the use of the device with the features and specifications to be tested to perform distance, intermediate and near activities. Prior to dispensing either device for a 2-week home trial evaluation, the patient must demonstrate to the satisfaction of the therapist a basic knowledge of and successful operational skill with the device, including an understanding that participants are not to attempt to walk or operate a vehicle while wearing the device.
Guided by the AI results, participants will be instructed on the types of activities participants should perform at home while using the device. The participant will also take part in baseline testing in 1. Facial recognition, 2.Visual motor test, 3. The International Reading Speed Texts (IReST) to assess reading performance, and 4. a modified Timed Activity of Daily Living (TIADL) performance test. The patient will be called during the 2-week home trial period and a Simulator Sickness Questionnaire (SSQ) will be administered. A follow-up AI will be administered at the end of the 2-week trial. The participant will return the headset to the laboratory after the 2-week trial and will be debriefed on participant's experiences and impressions. The 4 tests will be repeated at this visit (Facial recognition, Visual motor, IReST and TIADL). None of these procedures are part of or substitute for the patient's routine care. Investigators will employ rolling enrollment of participants on staggered schedules. Investigators expect to complete the 50th participant with the first condition in 22 weeks and then Investigators will start the crossover phase after the 22-week washout. Investigators expect to complete both phases with the first 50 patients (less drop outs) in year 1. Investigators then repeat the procedure with the next group of 50 participants in year 2, using systems that include new software features developed in response to participant feedback.
A treatment success is defined as an improvement in functional ability measured with the Activity Inventory that exceeds the 95% confidence interval of the estimated baseline measure [i.e.,Minimum Clinically Important Difference (MCID)]. Stopping the home trial will not be initiated by the investigators, but participants who are experiencing significant simulator sickness will be encouraged to stop.
Participants who stop the home trial prematurely will still be asked to complete the post-trial debriefing and the follow-up AI. Since study participation does not substitute for the patient's regular clinical care, there is no consequence to the patient for prematurely ending study participation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intention to treat design; crossover with 22 week washout period between interventions; primary outcome measure is patient-reported function
| Arm | Type | Receives |
|---|---|---|
| LVES 2 first LEGACY second | Experimental | Device: Virtual bioptic magnification with large field of view, Device: Full field magnification with small field of viewVirtual bioptic magnification with large field of view (LVES 2) followed by 22-week washout period and then Full field magnification with small field of view (LEGACY) |
| LEGACY first LVES 2 second | Active comparator | Device: Virtual bioptic magnification with large field of view, Device: Full field magnification with small field of viewFull field magnification with small field of view (LEGACY) followed by 22-week washout period and then Virtual bioptic magnification with large field of view (LVES 2) |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Visual acuity in the better-seeing eye 20/60-20/800
- Horizontal visual field extent >70 degrees diameter, vertical visual field extent >50 degrees.
- Indicate at least 2 goals from the Activity Inventory during the initial screening interview.
- Scores at least 27 in the Telephone Interview Cognitive Status during the initial screening interview
Key exclusion criteria (5 listed)
- Patients who are planning ocular surgery (including laser surgery) during the period of study participation or are early in anti-neovascular treatment (<6 injections)
- Younger than 14 years of age
- Unable to participate in a telephone interview
- Indicate less than 2 goals from the Activity Inventory
- Score less than 27 in the Telephone Interview Cognitive Status
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 bioptic magnification with large field of viewAlso: LVES 2, IrisVisionThe intervention device will have a larger field of vision than the legacy device and the intervention device will also have a virtual bioptic telescope mode not found on the legacy device. The user will be able to adjust the size of the virtual bioptic telescope and the amount of magnification with a touch pad on the side of the head-mounted display (HMD). | Device | LEGACY first LVES 2 second, LVES 2 first LEGACY second |
| Full field magnification with small field of viewAlso: LEGACYComparison intervention with user-controlled full field magnification with a smaller field size shared by legacy head-mounted devices. User can control amount of magnification | Device | LEGACY first LVES 2 second, LVES 2 first LEGACY second |
Primary outcome
Mean change in patients' self-reported functional ability as assessed by the Activity Inventory (AI) rating scale questionnaire
Time frame: 2 weeks, 24 weeks
Functional ability is estimated from difficulty ratings of items in the AI, a questionnaire that banks 510 items describing common activities. 50 items are "goals", broad descriptions of activity accomplishments. The other 460 items are "tasks", specific activities typically performed to achieve goals. The patient rates the importance of each goal. Unimportant goals are skipped, otherwise the patient rates the goal's difficulty. If "not difficult", the patient skips to the next goal, otherwise rates the difficulty of the goal's subsidiary tasks, or responds "not applicable". The average ability required by each item and the functional ability of each patient are estimated on the same scale with Rasch analysis. The 510 item measures in the AI are fixed to values for 3000 low vision patients. The investigators will analyze functional ability change score distributions for the two interventions before and after the crossover.
1 secondary outcome
Minimum Clinically Important Difference (MCID) in patient's self-reported functional ability estimated from difficulty ratings of activities in the AI rating scale questionnaire
Time frame: 2 weeks, 24 weeks
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 16 Feb 2021.
- Background: PubMed 30153240Deemer AD, Bradley CK, Ross NC, Natale DM, Itthipanichpong R, Werblin FS, Massof RW. Low Vision Enhancement with Head-mounted Video Display Systems: Are We There Yet? Optom Vis Sci. 2018 Sep;95(9):694-703. doi: 10.1097/OPX.0000000000001278.
- Background: PubMed 25856370Goldstein JE, Jackson ML, Fox SM, Deremeik JT, Massof RW; Low Vision Research Network Study Group. Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers. JAMA Ophthalmol. 2015 Jul;133(7):762-9. doi: 10.1001/jamaophthalmol.2015.0693.
- Background: PubMed 17700339Massof RW, Ahmadian L, Grover LL, Deremeik JT, Goldstein JE, Rainey C, Epstein C, Barnett GD. The Activity Inventory: an adaptive visual function questionnaire. Optom Vis Sci. 2007 Aug;84(8):763-74. doi: 10.1097/OPX.0b013e3181339efd.
- Derived from this study: PubMed 38551973Chun R, Deemer A, Fujiwara K, Deremeik J, Bradley CK, Massof RW, Werblin FS. Comparative effectiveness between two types of head-mounted magnification modes using a smartphone-based virtual display. Optom Vis Sci. 2024 Jun 1;101(6):342-350. doi: 10.1097/OPX.0000000000002115. Epub 2024 Apr 12.
- Individual participant dataSharing planned: Undecided. If individual participant data (IPD) is shared, it will be in the form of a csv data file included as supplemental material attached to the published results.
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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.
Robert W Massof, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual bioptic magnification with large field of view and Full field magnification with small field of view in people with Low Vision, run by Johns Hopkins University 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 4 inclusion and 5 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 16 Feb 2021. 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?
Mean change in patients' self-reported functional ability as assessed by the Activity Inventory (AI) rating scale questionnaire (time frame: 2 weeks, 24 weeks). 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 NCT03728660, which also lists 4 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 16 Feb 2021.