Prevalence of Diabetic Retinopathy in Type 2 Diabetic Patients

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06146699
• Other study ID #: Diabetic Retinopathy
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Abdelrahman M. Abdelhafez, resident
• Phone: +201010536251
• Email: dr.abdelrahmanhafez[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 262
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Gender: All
• Age group: 25 Years to 90 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Device:
• Optical Coherence Tomography (OCT)
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)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (12)

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	Baseline