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Trial record 4 of 70 for:    Recruiting Studies | Diabetic Retinopathy

Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study (SMART)

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ClinicalTrials.gov Identifier: NCT03572699
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Diacon Hospital
Information provided by (Responsible Party):
Dr Srikanth Y N, Medios Technologies Pte. Ltd

Brief Summary:
This is an observational cross sectional study aimed to evaluate the performance of the artificial intelligence algorithm in detecting any grade of diabetic retinopathy using retinal images from patients with diabetes.

Condition or disease Intervention/treatment
Diabetic Retinopathy Other: diabetic retinopathy

Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: diabetic retinopathy
    This is an observational study of patients with diabetes. Patients undergoing routine care will undergo retinal imaging using a nonmydriatic fundus camera. The images will be run on an artificial intelligence (AI) algorithm. The diagnosis of the artificial intelligence algorithm will be compared to the image diagnosis given by the ophthalmologists. The ophthalmologists will be blinded to the diagnosis of the AI and vice versa. The data will be analyzed to evaluate the performance of the AI.


Primary Outcome Measures :
  1. Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Sensitivity and specificity of the AI in detecting referable diabetic retinopathy (referable retinopathy defined as moderate non proliferative retinopathy or greater) [ Time Frame: 3 months ]
  2. Sensitivity and specificity of the AI in detecting sight threatening diabetic retinopathy (referable retinopathy defined as severe non proliferative retinopathy or greater) [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with diabetes mellitus presenting to the outpatient for routine clinical care.
Criteria

Inclusion Criteria:

  1. Patients with type 1 or type 2 diabetes mellitus
  2. Ages 18 and above
  3. Male and female

Exclusion Criteria:

  1. Persistent visual impairment in one or both eyes;
  2. Subjects with corneal opacities and advanced cataract.
  3. History of retinal vascular (vein or artery) occlusion;
  4. Subject is contraindicated for fundus photography (for example, has light sensitivity);
  5. Subject is currently enrolled in an interventional study of an investigational device or drug;
  6. Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572699


Contacts
Contact: Srikanth Y N, MS 9886450550 srikanthyn@yahoo.com
Contact: Bhavana Sosale, MD 9449478512 bhavanasosale@gmail.com

Locations
India
Diacon Hospital Recruiting
Bangalore, India, 560010
Contact: Bhavana Sosale         
Sponsors and Collaborators
Medios Technologies Pte. Ltd
Diacon Hospital
Investigators
Principal Investigator: Srikanth Y N, MS Investigator

Responsible Party: Dr Srikanth Y N, Principal investigator, Medios Technologies Pte. Ltd
ClinicalTrials.gov Identifier: NCT03572699     History of Changes
Other Study ID Numbers: SMART1
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases