Establishment of the National Registry for Inherited Retinal Dystrophy in Iran

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT04131400

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inherited Retinal Dystrophy Primarily Involving Sensory Retina Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium	Diagnostic Test: Visual Acuity Testing and Retinal Imaging

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Establishment of the National Registry for Inherited Retinal Dystrophy in Iran

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Research Center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zahra Rabbani Khah, Head of department, Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT04131400

Other Study ID Numbers:

2222

First Posted:

Oct 18, 2019

Last Update Posted:

Oct 18, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Dystrophies

Study Results

No Results Posted as of Oct 18, 2019