Clinical Data

What is the evidence?

Since commencing early stage user evaluation sessions in 2016, GiveVision now has over 1,100 visually impaired volunteers, and has completed a number of studies to provide evidence for our wearable sight aid technology.

Empirical Evidence & Efficacy Data

1,100+ patients taken part in large scale user testing since 2015. Over 80% testers reported improved ability to see.

Regulatory

SightPlus™ is registered as class I medical device in Europe.

Patient Studies

250+ patients took SightPlus™ home for a take home study for a period of 4 - 52 weeks. Three years on, almost 100 patients are still living with the device and rely on it daily.

Clinical Trials

Moorfields Eye Hospital conducted a clinical device trial of SightPlus™ and found that 98% of patients improved vision by an average of 6 lines on the sight chart. Paper published in the journal of the college of Optometrists

Download Data & Evidence Pack

Moorfields Eye Hospital
clinical trial

Evaluation of efficacy of electronic head-mounted Low Vision Aid (ehLVA) SightPlus™ (2019)

Methods:

Sixty participants with low vision aged 18 to 93 used SightPlus™ during an in‐clinic study session based on a mixed methods design. Visual acuity (ETDRS), contrast sensitivity (Pelli‐Robson) and reading performance (MNREAD) were measured binocularly at baseline, with the device in 'normal' mode, and with preferred enhanced mode.

Results:

Binocular distance visual acuity improved significantly by 0.63 logMAR on average (p < 0.0001) to 0.20 logMAR. Contrast sensitivity improved significantly by 0.22 log units (p < 0.0001) to 1.21 log units with zoom only and by 0.40 log units to 1.37 log units. Reading performance improved significantly for near visual acuity and critical print size (p < 0.015). SightPlus™ improved visual acuity in all but one patients

Primary Outcomes:

98%

improved vision by 31 EDTRS (average 0.6 logMar)

(n=60)

67%

achieved 0.2 logMar or better irrespective of baseline BCVA

(n=60)

Download the Paper

About Moorfields Eye Hospital

Moorfields Eye Hospital NHS Foundation Trust is the leading provider of eye health services in the UK and a world-class centre of excellence for ophthalmic research and education. Moorfields Hospital renowned for providing the highest quality of ophthalmic care and remains at the cutting edge of developments in ophthalmology.

For over 200 years Moorfields has pioneered research, employed the brightest minds and delivered visionary eye care and continue to set standards for the rest of the world to follow. Moorfields is a national and international centre for research into eye conditions and treatments, leading one of the strongest and most extensive ophthalmic research programmes in the world.

Patient reported outcomes

An in-depth, take-home evaluation
study of SightPlus™ (2016 - 2017)

83% reported improved ability to see and perform tasks compared to their best available coping strategy

Methodology:

Study participants (n=92) aged 18 - 86, with BCVA ranging between 0.6 and 1.5 logMar, used SightPlus™ at home for a period between 2 - 52 weeks

During a comprehensive de-brief based on a structured interview, participants were asked to self-rate their ability to see (or performa a task) with SightPlus in comparison to the participant's best available coping strategy (not their baseline ability to see).

Patient Reported Outcomes:

The study showed that SightPlus™ can support a wide variety of activities of daily living. Ratings for ability to see during commonly performed tasks increased substantially. In general, SightPlus performed better than participants' current coping strategies.

A total of 83% of testers reported that SightPlus™ improved their ability to see for any of their chosen use cases compared to their original coping strategy. See the diagram below for more details.

Watching TV

Hobbies & Work

Reading

Watching TV: 70%

The proportion of participants reporting a better ability to perform a task of watching TV with SightPlus™ compared to their ability to perform this activity using their best available coping strategy (typically: sitting right up close to the television screen).

Hobbies & Work: 78%

The proportion of participants reporting a better ability to perform an activity such as playing a musical instrument, sight-seeing, looking at a whiteboard, correcting student's homework, working on a PC, attending meetings / presentations, etc; with SightPlus™ compared to their best available coping strategy (often none available).

Reading: 51%

The proportion of participants reporting a better ability to perform a reading task (e.g. newspapers, magazines, books, etc) with SightPlus™, in comparison with their ability to perform the task with their best available coping strategy (usually magnifier or a desktop CCTV system)

SightPlus™ Health & Value pilot

Longitudinal, controlled follow-up study (2017)

Follow-up study designed to assess impact on quality of life for patients living with SightPlus device for a period of 6 to 18 months.

The SightPlus™ interventional cohort (n=34) was age, gender and condition balanced by a control cohort (n=9) to explore volunteer responsiveness and effect sizes.

The study captured self-reported, vision-related quality of life impact, using two validated questionnaires: National Eye Institute Visual Functioning Questionnaire (VFQ-39) and Manchester Low Vision Questionnaire (MLVQ)

Primary Outcomes:

Effect size 13 .1 points change in quality of life as measured by the VFQ-39 (p=0.036):

With SightPlus™
(n=34)

+8pt

Before SightPlus (or 6 months ago for controls) and 'now' (at the time of the survey)

Without SightPlus™
(n=9)

-5.1pt

The control group indicated a decrease in vision-related quality of life

65% of participants reported being able to do activities which they were not able to do without SightPlus™

Eighty-eight percent of participants reported having used SightPlus™ in the last four weeks, with 41% of respondents using it daily, often multiple times per day.

Participants used SightPlus™ for a variety of different activities defined in the MLVQ from reading different print sizes and materials to DIY, hobbies and watching sport events.

There was a statistically significant (p=0.036) improvement for testers on this measure (48.7 points to 53.4, on a scale from 0 to 100). This improvement amounted to 4.7 points across all participants and 5.2 points for adults only. Furthermore, the control group reported a decrease in quality of life over a period of six months (from 46.5 points to 43.6), increasing the effect size of SightPlus on quality of life overall.

The statistically significant improvements on the 10 VFQ subscales were those for near vision (improved by 11 points, p=0.005), distance vision (by 10 points, p=0.003) and role limitations, e.g. being limited by one's poor vision (by 6 points, p=0.024).

68% of participants reported an increase in self-confidence and 65% of participants reported being able to do activities which they were not able to do without SightPlus™ because of their sight condition.

Indications

SightPlus™ was shown to be effective for people suffering from vast number of sight conditions. Here are some of the most common sight conditions:

Macular Degeneration

Diabetic Retinopathy

Stargardt Disease

Usher Syndrome

Retinitis Pigmentosa (RP)

Leber Hereditary Optic Neuropathy

Glaucoma

Best Macular Dystrophy

Ocular Albinism

Optic Neuropathy

Cone-Rod Dystrophy

Leber Congenital Amaurosis

3+ years of take-home trials and over 100 participants later:

88%

Are still using device regularly

41%

are using it daily

75 min

daily mean average use time

Do you have an idea for research or a trial?

We work very closely with top academics and healthcare providers across the UK, Europe and US, and are running collaborative R&D projects, device studies & clinical trials.

Please get in touch if you would be interested in running a collaborative research project, study, pilot or trial evaluating patient outcomes /efficacy / cost effectiveness of wearable, electronic low vision aids; developing and piloting novel methods of measuring visual function; or improving outcomes for patients living with severe sight loss.

+44 (0)121 6303 063

Tintagel House, 92 Albert Embankment
London, United Kingdom

GiveVision is a purpose-driven organization operating on a not-for-dividend model. We reinvest at least 51% of our profits in the development of assistive technologies, funding pioneering research in visual impairment solutions, and providing pro-bono vision aids to those unable to afford them—ultimately fostering a more inclusive world for all.

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