Visual Rehabilitation of Patients With Myopic Maculopathy

Myopic Maculopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244074
• Other study ID #: BIO0210
• Status: Completed
• Phase: N/A
• First received: November 18, 2010
• Last updated: November 18, 2010

Study information

• Verified date: February 2010
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: University La Sapienza
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 35 Years to 57 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Myopic Maculopathy

Intervention

Behavioral:
• biofeedback training

Locations

Country	Name	City	State
Italy	University La Sapienza, Polo Pontino	Latina

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of visual performance
Secondary	improvement of visual acuity, retinal sensitivity, fixation stability