Establishment of the National Registry for Inherited Retinal Dystrophy in Iran

• Conditions: Inherited Retinal Dystrophy Primarily Involving Sensory Retina; Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium
• Interventions: Diagnostic Test: Visual Acuity Testing and Retinal Imaging

• Registration Number: NCT04131400
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Last Update Submitted: 2019-10-16
• Study First Posted: 2019-10-18
• Last Update Posted: 2019-10-18
• Primary Completion: 2019-11-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Inherited Retinal Dystrophy	Visual Acuity Testing and Retinal Imaging	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.

Primary Outcome Measures

Name	Time	Method
prevalence and incidence of the different types of inherited retinal dystrophy in different regions of Iran.	4 years	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.

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of