Inherited Retinal Dystrophy Primarily Involving Sensory RetinaNCT04131400
Establishment of the National Registry for Inherited Retinal Dystrophy in Iran
An observational study of Inherited Retinal Dystrophy Primarily Involving Sensory Retina and Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inherited Retinal Dystrophy Primarily Involving Sensory Retina, Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium
- What is being tested?
- Visual Acuity Testing and Retinal Imaging
- How many people
- 1,000 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2017to 1 Jun 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with a definite diagnosis of IRD diagnoses based on clinical examinations and genetic testing.
Who cannot join
- Individuals who have a suspected diagnosis of IRD disease
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Hamid Ahmadieh, MD, labbafi@hotmail.com, labbafi@hotmail.com
About this study
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
- Being tested
- Visual Acuity Testing and Retinal Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Acuity Testing and Retinal ImagingDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Visual Acuity Testing and Retinal Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Jan 2017
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inherited Retinal Dystrophy Primarily Involving Sensory RetinaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131400
- Sponsor's protocol ID
- 2222
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of the National Registry for Inherited Retinal Dystrophy in Iran
- ClinicalTrials.gov ID
- NCT04131400
- Acronym / sponsor ID
- 2222
- Conditions
- Inherited Retinal Dystrophy Primarily Involving Sensory Retina, Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Inherited Retinal Dystrophy | – | Diagnostic Test: Visual Acuity Testing and Retinal Imagingknown 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with a definite diagnosis of IRD diagnoses based on clinical examinations and genetic testing.
Key exclusion criteria (1 listed)
- Individuals who have a suspected diagnosis of IRD disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Acuity Testing and Retinal ImagingAll 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 | Diagnostic test | Patients with Inherited Retinal Dystrophy |
Primary outcome
prevalence and incidence of the different types of inherited retinal dystrophy in different regions of Iran.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inherited Retinal Dystrophy Primarily Involving Sensory Retina and Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence and incidence of the different types of inherited retinal dystrophy in different regions of Iran. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.