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Evaluation System and Clinical Application for Diabetic Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528720
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Guangdong Provincial People's Hospital

Brief Summary:
Diabetic retinopathy(DR) is one of the most common and serious microvascular complications of diabetes,which is the primary cause of vision loss of diabetic patients. The risk of blindness is 25 times that of healthy people.Fundus fluorescein angiography (FFA) is the gold standard for diagnosing the stage of diabetic retinopathy.However,FFA is an invasive examination which requires the patient to be in good physical condition and is not suitable for large-scale screening.Therefore, it is important to build up an evaluation system for early diagnosis of DR,which is more convenient, safer, and non-invasive.Firstly, this study will retrospectively analyze the FFA images of DR to find the earliest and most frequently occurring fundus quadrant.Secondly,based on the retrospective analysis results, a prospective comparative study will be conducted,which combines the fundus photography with optical coherence tomography angiography(angio-OCT) and physical indicators to find out whether it has consistency, sensitivity and specificity with FFA in diagnosing the stage of DR in order to build up a more effective,safer and faster evaluation system and clinical application for DR.

Condition or disease
Diabetic Retinopathy

Detailed Description:
Firstly, this study will retrospectively analyze the FFA images of DR to find the earliest and most frequently occurring fundus quadrant.Secondly,based on the retrospective analysis results, a prospective comparative study will be conducted,which combines the fundus photography with angio-OCT and physical indicators to find out whether it has consistency, sensitivity and specificity with FFA in diagnosing the stage of DR.Finally,based on all the results,to build up a more effective,safer and faster evaluation system and clinical application for DR.

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Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Other
Time Perspective: Other
Official Title: Evaluation System and Clinical Application for Diabetic Retinopathy
Actual Study Start Date : June 13, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The earliest and most frequently occurring fundus quadrant of diabetic retinopathy in fundus fluorescein angiography. [ Time Frame: 2 years ]
    The study is to find the earliest and most frequently occurring fundus quadrant of diabetic retinopathy.Based on the the retrospective analysis results, a prospective comparative study will be conducted to build up a evaluation system and clinical application for diabetic retinopathy.We divided the FFA images into nine quadrants: posterior pole, superior, superior nasal, nasal, inferior nasal, inferior, inferior temporal, temporal, and superior temporal. The qualitative analysis of diabetic retinopathy in each quadrant was performed. The earliest and most common fundus quadrant of diabetic retinopathy was then assessed using a rank sum test, t-test, and analysis of variance.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The retrospective study needs 150 people.The prospective comparative study needs 200 people.
Criteria

Inclusion Criteria:

Patients with diabetic retinopathy

Exclusion Criteria:

Refractive interstitial turbidity Cannot cooperate with examiner Retinal surgery in patients Malignant tumors Hematological diseases Immune diseases Glaucoma or other retinal diseases


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): NCT03528720


Locations
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China, Guangdong
Qianli Meng
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Guangdong Provincial People's Hospital
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Responsible Party: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT03528720    
Other Study ID Numbers: 2018188H
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangdong Provincial People's Hospital:
Tomography, Optical Coherence
Fluorescein Angiography
Fundus photographs
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases