Visual Rehabilitation of Patients With Myopic Maculopathy | NCT01244074

Studies
Visual Rehabilitation of Patients With Myopic Maculopathy

NCT01244074

Sponsor

University of Roma La Sapienza

Status

Completed

Last Update Posted

Nov 19, 2010Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Myopic Maculopathy

Interventions

biofeedback training

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 18, 2010

First Submission Date that Met QC Criteria

Nov 18, 2010

First Posted Date

Nov 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2010

Last Update Posted Date

Nov 19, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
biofeedback	Experimental		Behavioral: biofeedback training

Name	Type	Description	Arm Group Labels	Other Names
biofeedback training	Behavioral		biofeedback

Measure	Description	Time Frame
improvement of visual performance

Measure	Description	Time Frame
improvement of visual acuity, retinal sensitivity, fixation stability

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

57 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided