Prevalence of Diabetic Retinopathy in Type 2 Diabetic Patients

NCT06146699 | Unknown

• 1 other identifier: Diabetic Retinopathy
• Study Type: observational
• Target: 262
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Retinopathy

Outcome Measures

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 .

  Baseline

Interventions

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.

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• 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.

  PMID: 23537395 BACKGROUND

• 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.

  PMID: 27555623 BACKGROUND

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

  PMID: 17896294 BACKGROUND

• 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.

  PMID: 8750225 BACKGROUND

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

  PMID: 1299077 BACKGROUND

• 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.

  PMID: 31733978 BACKGROUND

• 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.

  PMID: 29032195 BACKGROUND

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

  PMID: 15228863 BACKGROUND

• 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.

  PMID: 24563789 BACKGROUND

• 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.

  PMID: 19940227 BACKGROUND

• 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.

  PMID: 27355693 BACKGROUND

• 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.

  PMID: 36964254 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Tomography, Optical Coherence; Fluorescein Angiography

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Angiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Ophthalmological

Study Officials

• Ashraf K. Al-Hussaini, prof

  Assiut University

  STUDY CHAIR

• Ahmed M. Fahmy Fathalla, prof

  Assiut University

  STUDY DIRECTOR

• Islam M. Mohamed Gouda

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Abdelrahman M. Abdelhafez, resident

CONTACT

+201010536251; dr.abdelrahmanhafez@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 27, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11