Establishment of the National Registry for Inherited Retinal Dystrophy in Iran

Study Overview
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Brief Summary
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Purpose: To establish of the national Inherited Retinal Dystrophy Registry (IRDR) in Iran. Methods: This study is a community-based participatory research that is approved by the Ministry of Health and Medical Education of Iran in 2016. To provide the minimum data set (MDS), several focus group meetings will be held with participation of the faculty members of the Ophthalmic Research Center affiliated to Shahid Beheshti University of Medical Sciences (SBMU). Final MDS will be presented to the software engineering team to develop a web-based software. In the pilot phase, software will be set up in two referral centers including Labbafinejad Medical Center (Tehran) and Alzahra Eye Hospital (Zahedan) to discover the possible drawbacks. Final diagnosis will be made based on both clinical manifestations as well as genetic findings.The steering committee meetings are planned to be held each year with the presence of delegates of all centers.

Official Title
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Establishment of the National Registry for Inherited Retinal Dystrophy in Iran

Conditions
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Inherited Retinal Dystrophy Primarily Involving Sensory Retina, Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium

Intervention / Treatment
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* Diagnostic Test: Visual Acuity Testing and Retinal Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a definite diagnosis of IRD diagnoses based on clinical examinations and genetic testing. Exclusion Criteria: Individuals who have a suspected diagnosis of IRD disease
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Inherited Retinal Dystrophy<br>known patients with a diagnosis of inherited retinal dystrophy (IRD) will be recruited to identify the type of IRD diagnosis. The comprehensive ophthalmic examinations and retinal imaging will be performed. Additionally, blood sample of all participants and their family members will be kept in our bio- bank for genetic testing. | Diagnostic Test: Visual Acuity Testing and Retinal Imaging<br>* All clinical and para- clinical tests including visual acuity assessment, perimetry, optical coherence tomography (OCT), enhanced depth- OCT, OCT angiography, color fundus, autofluorescence and infrared fundus photography will be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence and incidence of the different types of inherited retinal dystrophy in different regions of Iran. | The present study is designed to determine the prevalence and incidence of IRD diagnoses in different regions of Iran based on the crude data which will be registered in the Iranian IRD registry. | 4 years |