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Diabetic RetinopathyNCT06146699

Prevalence of Diabetic Retinopathy in Type 2 Diabetic Patients

An observational study of Diabetic Retinopathy, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine the stage of Diabetic Retinopathy (DR) and the presenting symptoms at the time of ophthalmological examination of diabetic individuals . Read more about this study

Who is it for?
Ages 25 to 90 years
Conditions the study is for
Diabetic Retinopathy
What is being tested?
Optical Coherence Tomography (OCT) and Fundus fluorescein angiography (FFA)
Type of treatment
Medical device
How many people
262 participants
Where
No sites listed yet
Study dates
Dec 2023to Feb 2025
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 25 to 90 years
  • All sexes
  • Adult, Older adult

Study population: All known diabetic patients ( type 2 ) or patients who were later on diagnosed with type 2 diabetes mellitus as per American Diabetes Association (ADA) criteria

Who may be able to join

  • All known diabetic patients ( type 2 ) or patients who were later on diagnosed with type 2 diabetes mellitus as per American Diabetes Association (ADA) criteria who presented for the first time to Assuit university hospital opthalomolgy outpatient clinics during study duration (one year) will be included in the study . Diabetic retinopathy will be classified according to Early Treatment Diabetic Retinopathy Study (ETDRS) classification as mild, moderate, severe and very severe non proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR). Patients with vitreous hemorrhage, rubeosis iridis, neovascular glaucoma or tractional retinal detachment will be classified as having advanced diabetic eye disease (ADED).

Who cannot join

  • Type 1 Diabetic patients or patients with diabetes below 25 years old will be excluded from the study .

Trial locations and contacts

No sites are listed yet.

Abdelrahman M. Abdelhafez, resident contact

+201010536251

dr.abdelrahmanhafez@gmail.com

About this study

Official title: Status of Diabetic Retinopathy and Its Presentation Patterns in Diabetics at Assiut University Hospital

To determine the stage of Diabetic Retinopathy (DR) and the presenting symptoms at the time of ophthalmological examination of diabetic individuals .

Read the detailed description

Diabetic retinopathy (DR) is the main cause of decreased vision and blindness in patients with diabetes throughout the world . In Egypt, the estimated prevalence of diabetes mellitus (DM) is expected to rise from 5-10% in the 1990s to>13% of the population over 20 years old by 2025 .

The estimation of the prevalence of diabetic retinopathy (DR) is challenging due to the great variation in the study populations, methodologies, and grading schemes .

Globally, the prevalence of DR and diabetic macular edema (DMO) is expected to rise from the estimates for the period 2015-2019 (27%) due to the expected increase in the life expectancy of people living with DM .

Diabetic retinopathy is now the 5th leading cause of blindness worldwide and is the main cause of blindness in working population .

Blindness due to diabetic retinopathy is more common in type 1 diabetics (4%) than in type 2 (1.6%) .

The exact mechanism of how prolonged hyperglycaemia causes retinopathy is still unclear, however studies have shown that prolonged hyperglycaemia alters retinal perfusion thereby disturbing the normal physiological and homeostatic state of the retina, in turn causing retinopathy .

Fortunately, much of the visual loss from DR is preventable, and the rates of vision loss from diabetes and DR have steadily declined over the past few decades. Such improvements in visual outcomes for DR are multifactorial, and are due in large part to a combination of better systemic risk factor control, coupled with advances in ocular disease assessment, screening, imaging and treatment in recent years .

Being tested
Optical Coherence Tomography (OCT), Fundus fluorescein angiography (FFA)
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optical Coherence Tomography (OCT)Device

    Optical Coherence Tomography (OCT) is a non-invasive diagnostic technique that renders an in vivo cross-sectional view of the retina.

  • Fundus fluorescein angiography (FFA)Device

    Fundus fluorescein angiography (FFA) is an invasive diagnostic procedure. It helps to assess the anatomy, physiology, and pathology of retinal and choroidal circulation. It aids in the diagnosis of various ocular pathologies.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prevalence of diabetic retinopathy

    To determine the stage of Diabetic Retinopathy (DR) and the presenting symptoms at the time of ophthalmological examination of diabetic individuals .

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2023
  2. Study startDec 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

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 only
Time perspective
Cross-sectional
Enrolment
262 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06146699
Sponsor's protocol ID
Diabetic Retinopathy
Status last verified
Nov 2023
First submitted
18 Nov 2023
Last updated
29 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Thapa SS, Thapa R, Paudyal I, Khanal S, Aujla J, Paudyal G, Rens Gv. Prevalence and pattern of vitreo-retinal diseases in Nepal: the Bhaktapur glaucoma study. BMC Ophthalmol. 2013 Mar 28;13:9. doi: 10.1186/1471-2415-13-9.

    PubMed 23537395

  • Leasher JL, Bourne RR, Flaxman SR, Jonas JB, Keeffe J, Naidoo K, Pesudovs K, Price H, White RA, Wong TY, Resnikoff S, Taylor HR; Vision Loss Expert Group of the Global Burden of Disease Study. Global Estimates on the Number of People Blind or Visually Impaired by Diabetic Retinopathy: A Meta-analysis From 1990 to 2010. Diabetes Care. 2016 Sep;39(9):1643-9. doi: 10.2337/dc15-2171.

    PubMed 27555623

  • Klein BE. Overview of epidemiologic studies of diabetic retinopathy. Ophthalmic Epidemiol. 2007 Jul-Aug;14(4):179-83. doi: 10.1080/09286580701396720.

    PubMed 17896294

  • Herman WH, Ali MA, Aubert RE, Engelgau MM, Kenny SJ, Gunter EW, Malarcher AM, Brechner RJ, Wetterhall SF, DeStefano F, et al. Diabetes mellitus in Egypt: risk factors and prevalence. Diabet Med. 1995 Dec;12(12):1126-31. doi: 10.1111/j.1464-5491.1995.tb00432.x.

    PubMed 8750225

  • Alwan A, King H. Diabetes in the eastern Mediterranean region. World Health Stat Q. 1992;45(4):355-9.

    PubMed 1299077

  • Thomas RL, Halim S, Gurudas S, Sivaprasad S, Owens DR. IDF Diabetes Atlas: A review of studies utilising retinal photography on the global prevalence of diabetes related retinopathy between 2015 and 2018. Diabetes Res Clin Pract. 2019 Nov;157:107840. doi: 10.1016/j.diabres.2019.107840. Epub 2019 Nov 14.

    PubMed 31733978

  • Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli MV, Das A, Jonas JB, Keeffe J, Kempen JH, Leasher J, Limburg H, Naidoo K, Pesudovs K, Silvester A, Stevens GA, Tahhan N, Wong TY, Taylor HR; Vision Loss Expert Group of the Global Burden of Disease Study. Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis. Lancet Glob Health. 2017 Dec;5(12):e1221-e1234. doi: 10.1016/S2214-109X(17)30393-5. Epub 2017 Oct 11.

    PubMed 29032195

  • Shaikh MZ. Diabetes mellitus--the continuing challenge. J Coll Physicians Surg Pak. 2004 Feb;14(2):63-4. No abstract available.

    PubMed 15228863

  • Tarr JM, Kaul K, Chopra M, Kohner EM, Chibber R. Pathophysiology of diabetic retinopathy. ISRN Ophthalmol. 2013 Jan 15;2013:343560. doi: 10.1155/2013/343560. eCollection 2013.

    PubMed 24563789

  • Wong TY, Mwamburi M, Klein R, Larsen M, Flynn H, Hernandez-Medina M, Ranganathan G, Wirostko B, Pleil A, Mitchell P. Rates of progression in diabetic retinopathy during different time periods: a systematic review and meta-analysis. Diabetes Care. 2009 Dec;32(12):2307-13. doi: 10.2337/dc09-0615.

    PubMed 19940227

  • Sabanayagam C, Yip W, Ting DS, Tan G, Wong TY. Ten Emerging Trends in the Epidemiology of Diabetic Retinopathy. Ophthalmic Epidemiol. 2016 Aug;23(4):209-22. doi: 10.1080/09286586.2016.1193618. Epub 2016 Jun 29.

    PubMed 27355693

  • Elmassry A, Ahmed ISH, Adly N, Torki M. Prevalence of diabetic retinopathy in patients with diabetes in Alexandria and North-West Delta, Egypt. Int Ophthalmol. 2023 Aug;43(8):2883-2895. doi: 10.1007/s10792-023-02692-4. Epub 2023 Mar 24.

    PubMed 36964254

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 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 29 Nov 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 Abdelrahman M. Abdelhafez, resident (+201010536251, dr.abdelrahmanhafez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prevalence of diabetic retinopathy (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06146699, which also lists 12 linked publications.

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 29 Nov 2023.

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