NCT02983305

Optical Head-Mounted Display Technology for Low Vision Rehabilitation

Completed NA Results posted Last updated 9 October 2019

What this trial tests

NA trial testing Head-Mounted Display in Retinal Dystrophies in 22 participants. Completed in 21 November 2018.

Timeline

26 June 2017

Primary endpoint
21 November 2018

21 November 2018

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	26 June 2017
Primary completion	21 November 2018
Estimated completion	21 November 2018
Sites	1 location across United States

Drugs / interventions tested

• Head-Mounted Display

Conditions studied

• Retinal Dystrophies — all drugs for Retinal Dystrophies →
• Healthy — all drugs for Healthy →

Sponsor

University of Michigan

Who can join

12 and older, any sex, with Retinal Dystrophies or Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared) Primary · Baseline and two to four weeks

Using computer software we will calculate the area of participants' Goldmann visual fields in order to obtain a summary quantitative measurement of the extent of peripheral vision. Average of both eyes visual fields with intervention.

Group	Value	95% CI
Retinal Dystrophy	563.08	331.97 – 715.60
Healthy Age-Matched Controls	-3799.19	-4482.99 – -2598.07

Change in Gait Speed Compared to Baseline (Measured in Seconds) Secondary · Baseline and two to four weeks

Gait speed will be measured using an inertial measurement unit attached to participants' shoes and will quantify the time taken to move from the beginning to end of a short mobility course. Average of data from both feet with intervention.

Group	Value	95% CI
Retinal Dystrophy	-.01	-.05 – 0.00
Healthy Age-Matched Controls	-.01	-.05 – .05

Sponsor's own description

The goal of this study is to examine the ability of optical head-mounted display technology to enlarge the visual field of patients with severe visual field loss due to retinal dystrophy and to improve mobility and patient-reported outcomes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Precision medicine to prevent glaucoma-related blindness.
   Moroi SE, Reed DM, Sanders DS, Almazroa A, et al · · 2019 · cited 26× · PMID 30883441 · DOI 10.1097/icu.0000000000000564