NCT05772780

Brief Summary

The objectives of this investigation are:

  • evaluate the results of rehabilitation treatment using photostimulation with a structured stimulus in two different samples of low vision subjects with central vision loss who will be subjected to biofeedback at the MP3 microperimeter with different timing;
  • compare the effectiveness of the rehabilitation treatments in the two groups to provide useful indications for proposing standardisation of the rehabilitation pathway focusing on photostimulation in subjects with central vision loss.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

February 21, 2023

Last Update Submit

March 6, 2023

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

  • Fixation stability

    Achievement of a stable fixation, defined according to Fuji classification (Stable: if more than 75% of the fixation points are inside a 2° diameter circle that has as a center the centroid of all fixation points) and the Bivariate Contour Ellipse Area, were selected as primary outcomes.

    6 months

  • Reading speed

    Achievement of good reading speed: higher than 87 words per minutes was defined as our secondary outcome. Parameters for words per minutes are referred to visually impaired functional reading reported in literature

    6 months

Study Arms (2)

Group A

EXPERIMENTAL

Training will be performed for two days a week

Device: MP-3 microperimeter

Group B

EXPERIMENTAL

Training will be performed three days a week

Device: MP-3 microperimeter

Interventions

MP-3 microperimeterDEVICE

Biofeedback stimulation two days a week

Group AGroup B

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age related macular degeneration

You may not qualify if:

  • Cognitive impairment; concomitant eye disease; significant media opacities; ocular surgery within previous 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 16, 2023

Study Start

October 1, 2021

Primary Completion

February 9, 2022

Study Completion

February 9, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)