Diabetic RetinopathyNCT05778370
Correlation Between HBA1c Level and Thickness of Both Macula and Choroid in Patients With Type 2 Diabetes Mellitus
An observational study of Diabetic Retinopathy, run by Assiut University.
Trial summary
Diabetic retinopathy (DR) is a frequent cause of visual impairment, and the leading cause of blindness in those of working age, but it develops silently along years, producing symptoms only in late stages. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Swept Source Optical Coherence Tomography(Topcon DRI Triton)
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2023to 1 Dec 2023
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Patients with type II diabetes mellitus and their age above 30 years. 2. healthy population above 30 (for control group)
Who may be able to join
- • Patients with type II diabetes mellitus and their age above 30 years.
- No history of any previous ocular surgery.
Who cannot join
- Unregulated arterial blood pressure, or cardiovascular disorder.
- Media opacity that affects posterior pole imaging by OCT
- Hyperopia of 4 diopters (D)
- Myopia of -6 D.
- Age related macular degeneration and other retinal or choroidal pathologies.
- Any history of previous eye surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Diabetic retinopathy (DR) is a frequent cause of visual impairment, and the leading cause of blindness in those of working age, but it develops silently along years, producing symptoms only in late stages.
Read the detailed description
The risk of sight-threatening consequences can be reduced if the lesions are detected before irreversible damage to retinal function has developed .Patients with diabetes mellitus (DM) have many pathological changes in their macula as diabetic macular edema (DME), exudates, cysts, detachment and ischemia that cause impairment of vision.
DME is characterized by increased vascular permeability and deposition of hard exudates at the macula and can occur at any stage of DR. With the help of OCT, it is possible to quantify the macular thickness objectively and to follow the progression of DME quantitatively.
Currently, DME is classified as 'center involved' or 'non center involved' (referring to whether or not there is oedema i.e., CMT>250 μm at the fovea) based on OCT. Non-centre involved macular oedema is rarely symptomatic. However, as the oedema spreads to the central macula, patients usually experience progressive vision loss and treatment with anti-VEGF is recommended.
Also, DM can cause many pathological changes in the choroid as increased tortuosity, focal vascular dilatation, microaneurysms and nonperfused areas. Studies have analyzed choroidal thickness changes in DR using spectral domain optic coherence tomography. A number of studies have shown that choroidal thickness decreases as the diabetic retinopathy progresses.
Swept-source (SS) OCT is a variation of OCT that offers improvements in visualizing the vitreous, retina, and choroid at one image. The increased scan speeds, decreased signal attenuation, more comprehensive imaging, and deeper tissue penetration make SS-OCT ideal for capturing a wide range of views and studying structures below the retinal pigmented epithelium (RPE), especially the choroid.
Glycated haemoglobin (HbA1c) is measured primarily to identify the average plasma glucose concentration over prolonged periods and reflect the long-term control of hyperglycaemia. Higher levels of HbA1c increase the incidence of DME over a 10-year period in Wisconsin Epidemiology Study of Diabetic Retinopathy (WESDR). The Diabetes Control and Complication Trial (DCCT) and the UK Prospective Diabetic Study (UKPDS) both of which were randomized prospective studies showed that intensive glycaemic control and thus reduction of HbA1c levels are associated with a decrease in the rates of development and progression of DR and DME.
The use of HbA1c for the diagnosis of DM has been approved by the WHO based on a number of epidemiological studies showing that a threshold for increased prevalence of microvascular complications can be observed at HbA1c level of 6.5% .
Aim of the work To investigate the correlation between HbA1c levels in patients with type II diabetes mellitus on central macular thickness as well as central choroidal thickness using swept source optical coherence tomography.
- Conditions
- Diabetic Retinopathy
- Being tested
- Swept Source Optical Coherence Tomography(Topcon DRI Triton)
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swept Source Optical Coherence Tomography(Topcon DRI Triton)Device
Topcon DRI Triton
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | will include 15 patients (30 eyes) of age matched non-diabetic candidates (control group) Receives: Device: Swept Source Optical Coherence Tomography(Topcon DRI Triton) | |
| Group 2 | will include 15 patients (30 eyes) of diabetic patients with good glycemic control (HbA1c ≤7%), Receives: Device: Swept Source Optical Coherence Tomography(Topcon DRI Triton) | |
| Group 3 | will include 15 patients (30 eyes) of diabetic patients with poor glycemic control (HbA1c <7% ( Receives: Device: Swept Source Optical Coherence Tomography(Topcon DRI Triton) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between HBA1c level and thickness of both macula and choroid in patients with type II diabetes mellitus
Taking oct record for diabetic patients already know their HBA1c level ( done within 3 months max ) . Without follow up Findings will be compared controlled and non controlled group and with control group (normal people) To correlate if there's relavence between the Hba1c and macular thickness
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start15 Apr 2023 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Gamal Nouby Mahmoud, Assiut University
- Investigators
- Mohamed S Saad, Prof, Study chair, Assiut UniversityMohamed Sharaf-Eldin, Dr, Study director, Assiut UniversityDalia M Ali, Dr, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778370
- Sponsor's protocol ID
- HBA1c and OCT Macula
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between HBA1c Level and Thickness of Both Macula and Choroid in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05778370
- Acronym / sponsor ID
- HBA1c and OCT Macula
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 21 Mar 2023 (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.
Diabetic retinopathy (DR) is a frequent cause of visual impairment, and the leading cause of blindness in those of working age, but it develops silently along years, producing symptoms only in late stages.
Detailed description
The risk of sight-threatening consequences can be reduced if the lesions are detected before irreversible damage to retinal function has developed .Patients with diabetes mellitus (DM) have many pathological changes in their macula as diabetic macular edema (DME), exudates, cysts, detachment and ischemia that cause impairment of vision.
DME is characterized by increased vascular permeability and deposition of hard exudates at the macula and can occur at any stage of DR. With the help of OCT, it is possible to quantify the macular thickness objectively and to follow the progression of DME quantitatively.
Currently, DME is classified as 'center involved' or 'non center involved' (referring to whether or not there is oedema i.e., CMT>250 μm at the fovea) based on OCT. Non-centre involved macular oedema is rarely symptomatic. However, as the oedema spreads to the central macula, patients usually experience progressive vision loss and treatment with anti-VEGF is recommended.
Also, DM can cause many pathological changes in the choroid as increased tortuosity, focal vascular dilatation, microaneurysms and nonperfused areas. Studies have analyzed choroidal thickness changes in DR using spectral domain optic coherence tomography. A number of studies have shown that choroidal thickness decreases as the diabetic retinopathy progresses.
Swept-source (SS) OCT is a variation of OCT that offers improvements in visualizing the vitreous, retina, and choroid at one image. The increased scan speeds, decreased signal attenuation, more comprehensive imaging, and deeper tissue penetration make SS-OCT ideal for capturing a wide range of views and studying structures below the retinal pigmented epithelium (RPE), especially the choroid.
Glycated haemoglobin (HbA1c) is measured primarily to identify the average plasma glucose concentration over prolonged periods and reflect the long-term control of hyperglycaemia. Higher levels of HbA1c increase the incidence of DME over a 10-year period in Wisconsin Epidemiology Study of Diabetic Retinopathy (WESDR). The Diabetes Control and Complication Trial (DCCT) and the UK Prospective Diabetic Study (UKPDS) both of which were randomized prospective studies showed that intensive glycaemic control and thus reduction of HbA1c levels are associated with a decrease in the rates of development and progression of DR and DME.
The use of HbA1c for the diagnosis of DM has been approved by the WHO based on a number of epidemiological studies showing that a threshold for increased prevalence of microvascular complications can be observed at HbA1c level of 6.5% .
Aim of the work To investigate the correlation between HbA1c levels in patients with type II diabetes mellitus on central macular thickness as well as central choroidal thickness using swept source optical coherence tomography.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Swept Source Optical Coherence Tomography(Topcon DRI Triton)will include 15 patients (30 eyes) of age matched non-diabetic candidates (control group) |
| Group 2 | – | Device: Swept Source Optical Coherence Tomography(Topcon DRI Triton)will include 15 patients (30 eyes) of diabetic patients with good glycemic control (HbA1c ≤7%), |
| Group 3 | – | Device: Swept Source Optical Coherence Tomography(Topcon DRI Triton)will include 15 patients (30 eyes) of diabetic patients with poor glycemic control (HbA1c <7% ( |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with type II diabetes mellitus and their age above 30 years. 2. healthy population above 30 (for control group)
Key inclusion criteria (2 listed)
- • Patients with type II diabetes mellitus and their age above 30 years.
Key exclusion criteria (6 listed)
- Unregulated arterial blood pressure, or cardiovascular disorder.
- Media opacity that affects posterior pole imaging by OCT
- Hyperopia of 4 diopters (D)
- Myopia of -6 D.
- Age related macular degeneration and other retinal or choroidal pathologies.
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 |
|---|---|---|
| Swept Source Optical Coherence Tomography(Topcon DRI Triton)Topcon DRI Triton | Device | Group 1, Group 2, Group 3 |
Primary outcome
Correlation between HBA1c level and thickness of both macula and choroid in patients with type II diabetes mellitus
Time frame: baseline
Taking oct record for diabetic patients already know their HBA1c level ( done within 3 months max ) . Without follow up Findings will be compared controlled and non controlled group and with control group (normal people) To correlate if there's relavence between the Hba1c and macular thickness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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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.
Mohamed S Saad, Prof study chair
Assiut University
Mohamed Sharaf-Eldin, Dr study director
Assiut University
Dalia M Ali, Dr principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Salma G Nouby, Resident (01124142121 ext. +20, salmanouby@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between HBA1c level and thickness of both macula and choroid in patients with type II diabetes mellitus (time frame: baseline). 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 21 Mar 2023.