Evaluation System and Clinical Application for Diabetic Retinopathy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03528720

Enrollment

225

Registered

2018-05-18

Start date

2017-06-13

Completion date

2018-04-30

Last updated

2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Tomography, Optical Coherence, Fluorescein Angiography, Fundus photographs

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.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The earliest and most frequently occurring fundus quadrant of diabetic retinopathy in fundus fluorescein angiography.	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.

Countries

China

Outcome results