Inherited Retinal Degenerative Disease Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02435940|
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : December 13, 2018
|Condition or disease|
|Eye Diseases Hereditary Retinal Disease Achromatopsia Bardet-Biedl Syndrome Bassen-Kornzweig Syndrome Batten Disease Best Disease Choroidal Dystrophy Choroideremia Cone Dystrophy Cone-Rod Dystrophy Congenital Stationary Night Blindness Enhanced S-Cone Syndrome Fundus Albipunctatus Goldmann-Favre Syndrome Gyrate Atrophy Juvenile Macular Degeneration Kearns-Sayre Syndrome Leber Congenital Amaurosis Refsum Syndrome Retinitis Pigmentosa Retinitis Punctata Albescens Retinoschisis Rod-Cone Dystrophy Rod Dystrophy Rod Monochromacy Stargardt Disease Usher Syndrome|
My Retina Tracker provides three different portals for data entry and review. An entry in My Retina Tracker is initiated by a participant, not a clinician. Using the Participant Portal, the participant establishes a username and password, is guided through on-line informed consent, and can then use an interactive guide to record their ophthalmic and family history, genotype and other subjective diagnosis-related information. Drop-down menus and standardized vocabulary are used for database consistency. They may also attach documents, such as medical records, to maintain personal files on their disease. Participants are encouraged to update their profiles regularly to create a longitudinal history of their disease. Participants can see aggregated data for all other participants in the registry and compare their own disease and status to others.
Once a participant profile has been established, participants may ask their clinician or genetic counselor to add specific ophthalmic exam and measurement results to the profile. This is done through the Clinical Portal which also uses a series of drop-down menus to expedite entry and standardize data. Clinicians cannot see the participant data when adding the clinical exam data. Participants are encouraged to collect this data at each medical exam, to create a longitudinal clinical data set.
Access to de-identified data is available through the Research Portal. Investigators may apply through the site for research access username and password. This access allows searching of both participant provided and clinical data and may also be used to pre-screen registrants as potential participants for research studies or clinical trials. A process that maintains patient anonymity and privacy protection, exists for researchers with Institutional Review Board-approved projects who wish to contact registry participants of interest.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||20000 participants|
|Target Follow-Up Duration:||20 Years|
|Official Title:||Foundation Fighting Blindness Registry, My Retina Tracker|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2037|
|Estimated Study Completion Date :||June 2037|
- Number of Participants with Rare Diagnoses Within the Inherited Retinal Degenerative Disease Category as Defined by Clinical Evaluation [ Time Frame: Data collection is ongoing, up to 20 years. ]Participant profiles broken out be disease category and genetic diagnosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435940
|Contact: Registry Coordinator||800-683-5555||Coordinator@MyRetinaTracker.org|
|United States, Maryland|
|Foundation Fighting Blindness||Recruiting|
|Columbia, Maryland, United States, 21046|
|Contact: Joan Fisher 800-683-5555 Coordinator@MyRetinaTracker.org|
|Principal Investigator: Brian Mansfield, PhD|
|Principal Investigator:||Brian Mansfield, PhD||Deputy Chief Research Officer|