Establishment of the National Registry for Inherited Retinal Dystrophy in Iran

Inherited Retinal Dystrophy Primarily Involving Sensory Retina Clinical Trial

Official title:

Establishment of the National Registry for Inherited Retinal Dystrophy in Iran

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04131400
• Other study ID #: 2222
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2019
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2021
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium
• Inherited Retinal Dystrophy Primarily Involving Sensory Retina
• Retinal Dystrophies

Intervention

Diagnostic Test:
• Visual Acuity Testing and Retinal Imaging
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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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