Design and Clinical Evaluation of a Smartphone-based Low Vision Enhancement System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2021-02-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Visual Outcomes of an Enhanced Monofocal Intraocular Lens Targeted for Monovision in Highly Myopic Eyes: a Randomized Controlled Trial

NCT07168109

Cataract High Myopia

NOT_YET_RECRUITING NA

Improving Glare and Visual Comfort for Patients With Visual Impairment

NCT05829135

Photophobia Visual Impairment Low Vision

WITHDRAWN NA

Vision Improvement for Patients With Age-Related Macular Degeneration

NCT04268836

Age-related Macular Degeneration

UNKNOWN NA

A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses

NCT03726606

Cataract Lenses Visual Impairment

UNKNOWN NA

Post-Approval Study of the Implantable Miniature Telescope

NCT01757132

AMD

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Low Vision

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Intention to treat design; crossover with 22 week washout period between interventions; primary outcome measure is patient-reported function

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Baseline AI administered prior to randomization, outcomes assessor masked on intervention assignment before and after crossover

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LVES 2 first LEGACY second

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)

Group Type EXPERIMENTAL

Virtual bioptic magnification with large field of view

Intervention Type DEVICE

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 view

Intervention Type DEVICE

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

LEGACY first LVES 2 second

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)

Group Type ACTIVE_COMPARATOR

Virtual bioptic magnification with large field of view

Intervention Type DEVICE

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 view

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual bioptic magnification with large field of view

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).

Intervention Type DEVICE

Full field magnification with small field of view

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LVES 2 IrisVision LEGACY

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

14 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No