Establishment of the National Registry for Inherited Retinal Dystrophy in Iran

NCT04131400 | Unknown

• 1 other identifier: 2222
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Inherited Retinal Dystrophy Primarily Involving Sensory Retina; Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with Inherited Retinal Dystrophy

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

Interventions

Visual Acuity Testing and Retinal Imaging DIAGNOSTIC_TEST

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

Patients with Inherited Retinal Dystrophy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

An initial registration will be performed only for subjects who has a diagnosis of IRD based on clinical and retinal imaging by an expert retina specialist, but definite diagnosis will be confirmed by genetic testing.

You may qualify if:

• Patients with a definite diagnosis of IRD diagnoses based on clinical examinations and genetic testing.

You may not qualify if:

• Individuals who have a suspected diagnosis of IRD disease

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: January 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: June 1, 2021
• Last Updated: October 18, 2019

Record last verified: 2019-10

Locations

IR (1)