N/A
Completed N=22
Optical Head-Mounted Display Technology for Low Vision Rehabilitation
Retinal Dystrophies · Healthy
Source: ClinicalTrials.gov NCT02983305 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: 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
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.
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 |
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
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. Informational only — not medical advice.