Diagnostic Accuracy of IDX-DR for Detecting Diabetic Retinopathy: A Systematic Review and Meta-Analysis

Khan Z 1 , Gaidhane AM 2 , Singh M 3 , Ganesan S 4 , Kaur M 5 , Sharma GC 6 Show all authors , Rani P 7 , Sharma R 8 , Thapliyal S 9 , Kushwaha M 10 , Kumar H 11 , Agarwal RK 12 , Shabil M 13 , Verma L 14 , Sidhu A 15 , Ab Manan NB 16 , Bushi G 17 , Mehta R 18 , Sah S 19 , Satapathy P 20 , Samal SK 21

Affiliations 

  • 1 Global Center for Evidence Synthesis, Chandigarh, India.. Electronic address: zaid.niper22@gmail.com
  • 2 Jawaharlal Nehru Medical College, and Global Health Academy, School of Epidemiology and Public Health. Datta Meghe Institute of Higher Education, Wardha, India.. Electronic address: abhay.psm@dmiher.edu.in
  • 3 Center for Global Health Research, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, India.. Electronic address: thesinghmp@gmail.com
  • 4 Department of Chemistry and Biochemistry, School of Sciences, JAIN (Deemed to be University), Bangalore, Karnataka, India.. Electronic address: g.subbulakshmi@jainuniversity.ac.in
  • 5 Department of Allied Healthcare and Sciences, Vivekananda Global University, Jaipur, Rajasthan 303012, India.. Electronic address: mkphd2024@gmail.com
  • 6 Department of Endocrinology, NIMS University, Jaipur, India.. Electronic address: girishchandra.sharma@nimsuniversity.org
  • 7 Chandigarh Pharmacy College, Chandigarh Group of College, Jhanjeri, Mohali 140307, Punjab, India.. Electronic address: Pooja.J3182@cgcjhanjeri.in
  • 8 Department of Chemistry, Raghu Engineering College, Visakhapatnam, Andhra Pradesh-531162, India.. Electronic address: sksharma.ramayanam@raghuenggcollege.in
  • 9 Uttaranchal Institute of Technology, Uttaranchal University, Uttarakhand, India.. Electronic address: shailendra@uumail.in
  • 10 IES Institute of Pharmacy, IES University, Bhopal, Madhya Pradesh 462044, India. Electronic address: monam.research@iesuniversity.ac.in
  • 11 New Delhi Institute of Management, Tughlakabad Institutional Area, New Delhi. India.. Electronic address: harish.kumar@ndimdelhi.org
  • 12 Department of Microbiology, Graphic Era (Deemed to be University) Clement Town Dehradun 248002, India.. Electronic address: rajatkumaragarwal.geims@geu.ac.in
  • 13 Noida Institute of Engineering and Technology (Pharmacy Institute), Greater Noida, India.. Electronic address: mohdshabil99@gmail.com
  • 14 Centre of Research Impact and Outcome, Chitkara University, Rajpura- 140417, Punjab, India.. Electronic address: lokesh.verma.orp@chitkara.edu.in
  • 15 Chitkara Centre for Research and Development, Chitkara University, Himachal Pradesh-174103, India.. Electronic address: amritpal.sidhu.orp@chitkara.edu.in
  • 16 University of Cyberjaya, Persiaran Bestari, Cyber 11, 63000 Cyberjaya, Selangor Darul Ehsan, Malaysia.. Electronic address: nor.hafizah@cyberjaya.edu.my
  • 17 School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, India.. Electronic address: ganeshbushi313@gmail.com
  • 18 Clinical Microbiology, RDC, Manav Rachna International Institute of Research and Studies, Faridabad, Haryana 121004, India.. Electronic address: mehtarachana41@gmail.com
  • 19 Department of Paediatrics, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Dr. D. Y. Patil Vidyapeeth, Pune 411018, Maharashtra, India.; Department of Public Health Dentistry, Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune 411018, Maharashtra, India.. Electronic address: sanjitsahnepal561@gmail.com
  • 20 University Center for Research and Development, Chandigarh University, Mohali, Punjab, India.; Medical Laboratories Techniques Department, AL-Mustaqbal University, 51001 Hillah, Babil, Iraq. Electronic address: prakasini.satapathy@gmail.com
  • 21 Unit of Immunology and Chronic Disease, Institute of Environmental Medicine, Karolinska Institutet, 17177 Stockholm, Sweden.. Electronic address: samalshaileshkumar@gmail.com
Am J Ophthalmol, 2025 Feb 20.
PMID: 39986640 DOI: 10.1016/j.ajo.2025.02.022

Abstract

PURPOSE: Diabetic retinopathy (DR) is a leading cause of vision loss worldwide, making early detection critical to prevent blindness. IDX-DR, an FDA-approved autonomous artificial intelligence (AI) system, has emerged as an innovative solution to improve access to DR screening. This systematic review and meta-analysis aimed to evaluate the diagnostic accuracy of IDX-DR in detecting diabetic retinopathy.

DESIGN: Systematic review and meta-analysis METHODS: A comprehensive literature search was conducted across PubMed, Embase, Scopus and Web of Science, identifying studies published through October 5, 2024. Studies involving adult patients with Type 1 or Type 2 diabetes and reporting diagnostic metrics such as sensitivity and specificity were included. The primary outcomes were pooled sensitivity and specificity of IDX-DR. A bivariate random-effects model was used for meta-analysis, and summary receiver operating characteristic (SROC) curves were generated to assess diagnostic performance. Statistical analyses were performed using MetaDisc software version 2.0.

RESULTS: Thirteen studies involving 13,233 participants met the inclusion criteria. IDX-DR's pooled sensitivity was 0.95 (95% CI: 0.82-0.99), and its pooled specificity was 0.91 (95% CI: 0.84-0.95). The SROC curve confirmed IDX-DR's high diagnostic accuracy in detecting diabetic retinopathy across various clinical environments. The AUC value of 0.95 demonstrated high sensitivity and specificity, indicating a robust diagnostic performance for IDX-DR in detecting diabetic retinopathy.

CONCLUSION: IDX-DR is a highly effective diagnostic tool for diabetic retinopathy screening, with robust sensitivity and good specificity. Its integration into clinical practice, especially in resource-limited settings, can potentially improve early detection and reduce vision loss. However, careful implementation is needed to address challenges such as over-diagnosis and ensure the tool complements clinical judgment. Future studies should explore the long-term impacts of AI-based screening and address ethical considerations surrounding its use.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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