CLINICAL TRIAL

Low Vision Rehabilitation for Vision, Low

Recruiting · 18+ · All Sexes · Boston, MA

NCT04926974

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About the trial for Vision, Low

Treatment Groups

This trial involves 3 different treatments. Low Vision Rehabilitation is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Low Vision Rehabilitation
BEHAVIORAL
Experimental Group 2
Low Vision Rehabilitation
BEHAVIORAL
Experimental Group 3
Low Vision Rehabilitation
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Ability to demonstrate proficiency with the smartphone and mobile app at 4 weeks post initial training
no previous use of the Aira app, Seeing AI app or Super Vision+ app on a smartphone (<5 uses in lifetime)
age 55 years + (no upper limit)
reside in New England states of MA, NH or RI (for subjects enrolled at NECO)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Low Vision Rehabilitation will improve 1 primary outcome, 6 secondary outcomes, and 3 other outcomes in patients with Vision, Low. Measurement will happen over the course of administered at time of enrollment.

Telephone Interview of Cognitive Status (TICS)
ADMINISTERED AT TIME OF ENROLLMENT
questionnaire; with subscales 0 to 1, with higher scores indicating greater cognitive ability.
Aira Explorer Survey post intervention feedback
6 MONTHS
(specific to those participants randomized to Aira); questionnaire, with subscales ranging from 0 to 10, higher scores indicate stronger agreement or helpfulness of the Aira App.
Psychosocial Impact of Assistive Devices Scale (PIADS)
ADMINISTERED AT 3-MONTHS POST-INTERVENTION AND 6-MONTHS POST-INTERVENTION
questionnaire; with subscales from -3 to 3, higher scores indicate greater affinity of a particular factor to assistive technology use.
App usage frequency
AT 3 MONTHS POST-INTERVENTION AND 6 MONTHS POST INTERVENTION
App usage in minutes.
Visual ability change score
AI QUESTIONNAIRE WILL BE ADMINISTERED THREE TIMES OVER 6 MONTHS: BASELINE, 3-MONTHS POST-INTERVENTION AND 6-MONTHS POST-INTERVENTION
The primary outcome measure is the person change score (before and after intervention), from the adaptive Massof Activity Inventory (AI) Questionnaire. The AI has an item bank of 510 items organized into 50 goals and 460 related visually-based tasks. Subscales range from 0 (not important) to 3 (very important). For those goals rated as important, subjects are asked to rate the task difficulty on subscales of 0 (impossible to do without help) to 5 (not difficult). Rasch analysis is employed to estimate visual ability from these difficulty ratings, on an interval scale. With Rasch analysis person measures are estimated, whereby a more positive person measure reflects greater visual ability. In this study, we will explore the the difference in person measures (i.e. change score) after the intervention at 3 and 6 months. A larger, more positive change score indicates greater visual ability since intervention.
Community Living: Life Space Questionnaire
WILL BE ADMINISTERED THREE TIMES OVER 6 MONTHS: BASELINE, 3-MONTHS POST-INTERVENTION AND 6-MONTHS POST-INTERVENTION
questionnaire; subscales range from 1 (Yes) to 2 (No), with a higher total value indicating a more restricted life space.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of vision, low?

Symptoms of low vision include blurred central vision. These symptoms are common after age of 65, may be noticeable even in midlife, and can be treated. There may also be problems focusing on text and performing small or fine details like writing, cutting or sewing. Patients may wish to be able to read a newspaper or use a computer at home or at work. The patients may also prefer to read to self-assess and self-validate. Vision, low syndrome may be an undertreated disorder. It is recommended that more knowledge of symptoms be disseminated and more effective methods of identifying low vision be developed.

Anonymous Patient Answer

What causes vision, low?

Vision, low may be one of the key reasons that causes individuals to be anxious about their visual abilities. It may also explain why it is difficult to find the right preventive strategies among those without vision, since sight is a vital sense. We also suggest that more research, using qualitative methodology, is necessary to identify the cause(s) of vision, low.

Anonymous Patient Answer

Can vision, low be cured?

Given that the present study is the first to report the prevalence, characteristics and treatment outcome of patients with refractive low vision and that refractive low vision has been described before in patients with low vision with high myopia (myopic lazy eyes), it has been concluded that the vision, low type is one type of refractive lazy eye. However, patients with refractive low vision not having any visual complaints or vision correction (only myopic lazy eyes) will not be treated by refraction plus glasses. Therefore, in the clinic, only refractive, low vision is diagnosed not only by a refraction in a standard way which is an outpatient clinic but also by an eye chart.

Anonymous Patient Answer

What are common treatments for vision, low?

The majority of patients were prescribed a spectacle or eyeglasses for refractive errors. There are more than twenty-five types of lens solutions available, from single-use to carefully labeled solutions as to the correct preservative or preservative replacement, correct type, strength, and duration of the solution and the type of solution for each prescription. Contact lenses are commonly prescribed to treat mild to moderate dry eyes or corneal opacities. Contact lenses can be cleaned with the solution included in the solution, worn in conjunction with eye drops, or used as a contact lens solution.

Anonymous Patient Answer

How many people get vision, low a year in the United States?

Vision (both total and ophthalmic) and eye health metrics have improved in the U.S. over the last decade. Sight-lost is much lower now than it was in the early 1990s. The reasons for this improvement may not be entirely due to vision screenings, but are more likely due to changes in diagnostic techniques, the increased availability and accuracy of eye care services, and better eye care education and accessibility in the U.S.. In particular, children are much more likely to have access to an ophthalmologist as compared to 10 years ago.

Anonymous Patient Answer

What is vision, low?

The first line of care for patients with vision, low, involves an appropriately trained family doctor in the context of their health care team. Physicians should be able to provide high quality, patient-centred, primary care with access to specialist care when appropriate.

Anonymous Patient Answer

How serious can vision, low be?

The vision, low was determined solely based on self-image and a brief history of vision loss. If vision is impaired in a person without an additional major systemic (i.e. systemic connective tissue) disorder, vision, low is not a vision issue.

Anonymous Patient Answer

Is low vision rehabilitation typically used in combination with any other treatments?

There may be indications for using low vision rehabilitation in combination with visual rehabilitation after bilateral cataract surgery. This may be beneficial in cases of a weak pretreatment vision of 20/200 or worse and a strong deficit in central visual acuity after surgery. If a patient has already had a cataract extraction surgery, visual rehabilitation is not mandatory, unless they have a vision of 20/200 or worse. In the case of preoperative vision 20/200 or lower a new surgery should be discussed. Patients with a good visual acuity of 20/400 or better should routinely receive this rehabilitatory program after cataract surgery.

Anonymous Patient Answer

Have there been any new discoveries for treating vision, low?

While [new treatments are being developed to treat eye diseases on a regular basis, most recent discoveries have come from [diseases of the retina] on their outer layers of the retina, such as cataracts. If the disease is localized to one area of the retina, then you can get vision if you can get the disease localized. (https://www.eMedicine.com/articles.

Anonymous Patient Answer

What are the common side effects of low vision rehabilitation?

Low vision rehabilitation may produce a range of side effects. These side effects may be predictable, and may be ameliorated by appropriate intervention. In particular, attention to correct visual presentation and correct and appropriate light level lighting before and during training may help reduce the severity of such symptoms.

Anonymous Patient Answer

Has low vision rehabilitation proven to be more effective than a placebo?

This randomized, controlled, open multicenter study demonstrated that patients who received low vision rehabilitation services were significantly more satisfied with vision-related performance than those who received a placebo service.

Anonymous Patient Answer

Is low vision rehabilitation safe for people?

People with low vision reported increased levels of well-being and satisfaction when they received support from an optometrist. When combined with appropriate rehabilitation, such support appears to be safe and acceptable to patients, family, and carers.

Anonymous Patient Answer
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