Visual Rehabilitation of Patients With Myopic Maculopathy

This study has been completed.
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01244074
First received: November 18, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Myopic Maculopathy
Behavioral: biofeedback training

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • improvement of visual performance

Secondary Outcome Measures:
  • improvement of visual acuity, retinal sensitivity, fixation stability

Arms Assigned Interventions
Experimental: biofeedback Behavioral: biofeedback training

  Eligibility

Ages Eligible for Study:   35 Years to 57 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • The investigators have excluded patients with other eye diseases (glaucoma, AMD, retinal detachment, etc.), uncooperative patients and persons with opacity of the dioptric media.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01244074

Locations
Italy
University La Sapienza, Polo Pontino
Latina, Italy, 04100
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01244074     History of Changes
Other Study ID Numbers: BIO0210
Study First Received: November 18, 2010
Last Updated: November 18, 2010
Health Authority: Italy: University La Sapienza

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 19, 2014