Suspended

Novel Quantification Methods for Fundus Flavoprotein Fluorescence and Lipofuscin Fluorescence to Detect Progression in Stargardt Disease

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Eye Diseases+6

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

+ Retinal Degeneration

From 5 to 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: September 2012
See protocol details

Summary

Principal SponsorUniversity of Michigan
Last updated: November 8, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

This study will evaluate whether more sophisticated testing and analytic methodologies, including fundus autofluorescence (FAF) and a novel non-invasive method to measure retinal flavoprotein fluorescence (FPF) may be used to better predict Stargardt macular dystrophy progression and monitor treatment effects than conventional modalities such visual acuity and visual field. This method involves the use of novel statistical methods to assess the heterogeneity of fundus autofluorescence images. Participants will complete 3 visits to the University of Michigan Kellogg Eye Center. Each visit will take approximately 2.5 hours. The initial visit will include a routine clinical eye examination, measurement of best-corrected visual acuity, indirect ophthalmoscopy, microperimetry, frequency-domain optical coherence tomography, Goldmann visual fields, fundus flavoprotein fluorescence (FPF) imaging, and fundus autofluorescence (FAF) and fundus photography. Patients will return for evaluation at 6 and 12 months after their initial visit to repeat testing and imaging.

Principal SponsorUniversity of Michigan
Last updated: November 8, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRetinal DegenerationRetinal DiseasesEye Diseases, HereditaryGenetic Diseases, InbornStargardt DiseaseMacular DegenerationRetinal Dystrophies

Criteria

4 inclusion criteria required to participate
Between the age of 5 and 18 years old

Clinical diagnosis of Stargardt Disease

Molecular confirmation of Stargardt Disease (with 2 identified mutations in ABCA4)

Visual acuity better than 20/100

2 exclusion criteria prevent from participating
A diagnosis of any other retinal degenerative disease

Limited central vision, defined as visual acuity worse than 20/100

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Kellogg Eye Center

Ann Arbor, United StatesOpen Kellogg Eye Center in Google Maps
SuspendedOne Study Center