Back to resultsVisual Rehabilitation of Patients With Myopic Maculopathy
Primary Purpose
Myopic Maculopathy
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
biofeedback training
Sponsored by
About this trial
This is an interventional trial for Myopic Maculopathy
Eligibility 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.
Sites / Locations
- University La Sapienza, Polo Pontino
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
biofeedback
Arm Description
Outcomes
Primary Outcome Measures
improvement of visual performance
Secondary Outcome Measures
improvement of visual acuity, retinal sensitivity, fixation stability
Full Information
NCT ID
NCT01244074
First Posted
November 18, 2010
Last Updated
November 18, 2010
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01244074
Brief Title
Visual Rehabilitation of Patients With Myopic Maculopathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Maculopathy
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
biofeedback
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
biofeedback training
Primary Outcome Measure Information:
Title
improvement of visual performance
Secondary Outcome Measure Information:
Title
improvement of visual acuity, retinal sensitivity, fixation stability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
57 Years
Eligibility 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.
Facility Information:
Facility Name
University La Sapienza, Polo Pontino
City
Latina
ZIP/Postal Code
04100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Visual Rehabilitation of Patients With Myopic Maculopathy
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