N/A N=22 Treatment

Optical Head-Mounted Display Technology for Low Vision Rehabilitation

Retinal Dystrophies · Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02983305 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared) — 563.08; -3799.19 degrees^2 — p=.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Head-Mounted Display (Device)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)	563.08; -3799.19	.0001 sig
SECONDARY Change in Gait Speed Compared to Baseline (Measured in Seconds)	-.01; -.01	0.38

Summary

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.

Eligibility Criteria

Inclusion criteria for subjects with retinal dystrophy:

diagnosis of retinal dystrophy
severe vision loss that constitutes legal blindness
able to perform a reliable Goldmann visual field test
constricted visual field less than or equal to 20 degrees by Goldmann perimetry using the III4e stimulus in at least one eye with best-corrected visual acuity ≥ 20/60

Inclusion criteria for control subjects:

healthy controls
visit history with the Comprehensive and Pediatric Ophthalmology Services at the University of Michigan
able to perform a reliable Goldmann visual field test

Exclusion criteria for subjects with retinal dystrophy:

movement disorder that precludes evaluation of mobility
functional vision loss
pregnant women

Exclusion criteria for control subjects:

visually significant ocular condition other than correctable refractive error
movement disorder that precludes evaluation of mobility
functional vision loss
pregnant women

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02983305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.