NCT00140491

Brief Summary

The goal of this pilot study is to evaluate the effect of Vision Restoration Therapy, VRT, on the visual function of patients with unilateral or bilateral AION, who have good central vision (at least 20/60) and altitudinal visual field defects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

1.7 years

First QC Date

August 30, 2005

Last Update Submit

October 22, 2013

Conditions

Non-Arteritic Anterior Ischemic Optic Neuropathy

Keywords

Non-Arteritic Anterior Ischemic Optic NeuropathyVisual Field DefectNeuroplasticityRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Visual Function

Interventions

Vision Restoration Therapy (NOVAVISION)DEVICE

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients seen by Dr Biousse or Dr Newman in the Neuro-Ophthalmology Unit at Emory University.
  • Age ≥ 30 years.
  • Uni- or bilateral AION (in case of bilateral AION, only one eye will be included in the study).
  • Best corrected visual acuity of at least 20/60 in the study eye
  • Altitudinal or arcuate visual field defect, splitting fixation by \>10 decibel difference above and below horizontal meridian.
  • Patient willing, and able, to spend 60 minutes-a-day for 6 months working on a computer.

You may not qualify if:

  • Patient cognitively or physically unable to perform reliable automated perimetry testing (on the 24-2 SITA Standard program) (which is grossly equivalent to the effort and attention needed to perform VRT daily at home).
  • Other cause of optic neuropathy.
  • Associated ocular disease requiring treatments or responsible for visual loss (such as untreated significant cataract, glaucoma, age related macular degeneration, etc…).
  • Visual acuity worse than 20/60 in the study eye.
  • Non-stable visual field defect on previous evaluations.
  • Epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Eye Center

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Jung CS, Bruce B, Newman NJ, Biousse V. Visual function in anterior ischemic optic neuropathy: effect of Vision Restoration Therapy--a pilot study. J Neurol Sci. 2008 May 15;268(1-2):145-9. doi: 10.1016/j.jns.2007.12.001. Epub 2008 Jan 22.

    PMID: 18207164RESULT

Study Officials

  • Valerie Biousse, MD

    Emory Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

August 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

US(1)