Visual Rehabilitation of Patients With Myopic Maculopathy

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. Identifier: NCT01244074
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : November 19, 2010
Information provided by:
University of Roma La Sapienza

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.

Condition or disease Intervention/treatment Phase
Myopic Maculopathy Behavioral: biofeedback training Not Applicable

Study Type : Interventional  (Clinical Trial)

Arm Intervention/treatment
Experimental: biofeedback Behavioral: biofeedback training

Primary Outcome Measures :
  1. improvement of visual performance

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

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Ages Eligible for Study:   35 Years to 57 Years   (Adult)
Sexes Eligible for Study:   All

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.

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 identifier (NCT number): NCT01244074

University La Sapienza, Polo Pontino
Latina, Italy, 04100
Sponsors and Collaborators
University of Roma La Sapienza Identifier: NCT01244074     History of Changes
Other Study ID Numbers: BIO0210
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases