Diabetes Mellitus, Type 2NCT04436900
Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy
A study testing Panretinal Photocoagulation (PRP) in people with Diabetes Mellitus, Type 2, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
The present study is a semi-experimental clinical trial that 20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Panretinal Photocoagulation (PRP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 10 Apr 2018to 10 Apr 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes Mellitus, Type 2 with PDR
- Having conscious satisfaction
Who cannot join
- Patients with a history of other eye diseases
- Patients with a history of previous laser treatment
- Patients with a history of injection of Anti-VGEF
- Patients with Vitreous hemorrhage
- Patients with Macula edema
- Patients with myopia more than -3 diopters or hyperopiamore than +3 diopters
Trial locations and contacts
1 site in 1 country.
About this study
The present study is a semi-experimental clinical trial that 20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms. The variables of contrast sensitivity, macula thickness under fovea , BCVA, the width of thyroid under fovea , RNFL thickness in the four areas around the disc, and the quality of life questionnaire of all patients were recorded at the beginning of the study.Retinal and choroid under fovea thickness and RNFL thickness were assessed in four areas, one week and one month after the end of treatment, and all the variables mentioned earlier were evaluated three months after PRP surgery.
This study is single group that the outcomes are compared before and after the intervention
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Panretinal Photocoagulation (PRP)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panretinal Photocoagulation (PRP)Procedure or surgery
PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms. Receives: Procedure: Panretinal Photocoagulation (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Quality
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease Which is measured by a quality of life questionnaire
Measured: up to 3 months
RNFL
retinal nerve fiber layer which measured by PP-OCT (optical coherence tomography)
Measured: up to 30 days
BCVA
best corrected visual acuity which measured by SD-OCT
Measured: up to 3 months
Retinal thickness in the central part of Fovea
Measured by SD-OCT
Measured: up to 30 days
Choroid thickness in the central part of Fovea
Measured by EDI-OCT
Measured: up to 30 days
Physical examination of PDR
An eye exam performed by an ophthalmologist will determine if there is retinopathy
Measured: up to 3 months
Contrast sensitivity
Contrast sensitivity which measured by Melbourne edge test
Measured: up to 3 months
Angiography with fluorescein
By injecting fluorescein into the vein and then taking an X-ray to diagnose PDR
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start10 Apr 2018
- Primary completion10 Feb 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436900
- Sponsor's protocol ID
- IR.BMSU.REC.1396.455
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04436900
- Acronym / sponsor ID
- IR.BMSU.REC.1396.455
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 10 Feb 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 18 Jun 2020 (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.
The present study is a semi-experimental clinical trial that 20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms. The variables of contrast sensitivity, macula thickness under fovea , BCVA, the width of thyroid under fovea , RNFL thickness in the four areas around the disc, and the quality of life questionnaire of all patients were recorded at the beginning of the study.Retinal and choroid under fovea thickness and RNFL thickness were assessed in four areas, one week and one month after the end of treatment, and all the variables mentioned earlier were evaluated three months after PRP surgery.
This study is single group that the outcomes are compared before and after the intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Panretinal Photocoagulation (PRP)20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes Mellitus, Type 2 with PDR
- Having conscious satisfaction
Key exclusion criteria (6 listed)
- Patients with a history of other eye diseases
- Patients with a history of previous laser treatment
- Patients with a history of injection of Anti-VGEF
- Patients with Vitreous hemorrhage
- Patients with Macula edema
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 |
|---|---|---|
| Panretinal Photocoagulation (PRP)PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms. | Procedure or surgery | Intervention group |
Primary outcome
Life Quality
Time frame: up to 3 months
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease Which is measured by a quality of life questionnaire
RNFL
Time frame: up to 30 days
retinal nerve fiber layer which measured by PP-OCT (optical coherence tomography)
BCVA
Time frame: up to 3 months
best corrected visual acuity which measured by SD-OCT
Retinal thickness in the central part of Fovea
Time frame: up to 30 days
Measured by SD-OCT
Choroid thickness in the central part of Fovea
Time frame: up to 30 days
Measured by EDI-OCT
Physical examination of PDR
Time frame: up to 3 months
An eye exam performed by an ophthalmologist will determine if there is retinopathy
Contrast sensitivity
Time frame: up to 3 months
Contrast sensitivity which measured by Melbourne edge test
Angiography with fluorescein
Time frame: up to 3 months
By injecting fluorescein into the vein and then taking an X-ray to diagnose PDR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panretinal Photocoagulation (PRP) in people with Diabetes Mellitus, Type 2, run by Baqiyatallah Medical Sciences University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 18 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life Quality (time frame: up to 3 months). The study lists 8 primary outcomes in all. 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 Jun 2020.