Low Vision Clinical Trial
— eLVESOfficial title:
Design and Clinical Evaluation of a Smartphone-based Low Vision Enhancement System
Verified date | December 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | February 5, 2021 |
Est. primary completion date | February 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Eye Institute (NEI), Visionize, LLC |
United States,
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. — View Citation
Goldstein 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. — View Citation
Massof 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 weeks, 24 weeks | |
Secondary | 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. | 2 weeks, 24 weeks |
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