CClinicalTrials.gg
Not yet recruitingNCT06146699Updated Nov 29, 2023

Prevalence of Diabetic Retinopathy in Type 2 Diabetic Patients

An observational study in Diabetic Retinopathy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 25 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
262
Ages
25 Years to 90 Years
Sex
All
01

Study summary

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 .

02

Conditions studied

  • Diabetic Retinopathy
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's planned enrollment of 262 is above the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

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

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • Type 1 Diabetic patients or patients with diabetes below 25 years old will be excluded from the study .
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
262 participants (estimated)
Patient registry
No

Interventions

  • DeviceOptical Coherence Tomography (OCT)

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

  • DeviceFundus fluorescein angiography (FFA)

    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.

06

What researchers measure

Primary outcomes

  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 .

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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. Erratum In: Diabetes Care. 2016 Nov;39(11):2096. doi: 10.2337/dc16-er11. 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06146699
Lead sponsor
Assiut University
Responsible party
Abdelrahman Mohamed Abdelhafez Mohamed (Principal Investigator, Assiut University) — Principal investigator
First posted
Nov 27, 2023
Start date
Dec 2023 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Feb 2025 (estimated)
Last update
Nov 29, 2023

Study contacts

Abdelrahman M. Abdelhafez, resident
Contact
dr.abdelrahmanhafez@gmail.com
+201010536251
Ashraf K. Al-Hussaini, prof
study chair · Assiut University
Ahmed M. Fahmy Fathalla, prof
study director · Assiut University
Islam M. Mohamed Gouda
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion