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Visual Rehabilitation of Patients With Myopic Maculopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244074
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Roma La Sapienza
  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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 57 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244074


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

ClinicalTrials.gov Identifier: NCT01244074     History of Changes
Other Study ID Numbers: BIO0210
First Submitted: November 18, 2010
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases