NCT01244074

Brief Summary

The Visual Pathfinder (LACE inc.) offers a non- invasive, patient- centered visual rehabilitation system based on an acoustic biofeedback. The investigators wanted to evaluate its usefulness in the improvement of visual function in visually impaired patients with high myopia.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
Last Updated

November 19, 2010

Status Verified

February 1, 2010

First QC Date

November 18, 2010

Last Update Submit

November 18, 2010

Conditions

Myopic Maculopathy

Outcome Measures

Primary Outcomes (1)

  • improvement of visual performance

Secondary Outcomes (1)

  • improvement of visual acuity, retinal sensitivity, fixation stability

Study Arms (1)

biofeedback

EXPERIMENTAL
Behavioral: biofeedback training

Interventions

biofeedback trainingBEHAVIORAL
biofeedback

Eligibility Criteria

Age35 Years - 57 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • high myopia (range 9-15 D) visited at the Outpatient Medical Retina's Hospital A. Fiorini Terracina (LT), University of Rome "La Sapienza", Polo Pontino. The diagnosis of myopic maculopathy was made on the basis of a comprehensive ophthalmological evaluation which included: biomicroscopic examination of anterior and posterior segment, fluorescein angiography (FAG) (Heidelberg HRA-2, FA module Heidelberg, Germany), optical coherence tomography (OCT), Spectral Domain (Heidelberg HRA-2, OCT module Heidelberg, Germany) and microperimetry with microperimeter MP-1 (Nidek Technologies, Padova, Italy).

You may not qualify if:

  • The investigators have excluded patients with other eye diseases (glaucoma, AMD, retinal detachment, etc.), uncooperative patients and persons with opacity of the dioptric media.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University La Sapienza, Polo Pontino

Latina, 04100, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Last Updated

November 19, 2010

Record last verified: 2010-02

Locations

IT(1)