Evaluation System and Clinical Application for Diabetic Retinopathy

NCT ID: NCT03528720

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-13
• Study Completion Date: 2018-04-30

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.

Conditions

Diabetic Retinopathy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qianli Meng

Guangzhou, Guangdong, China

Countries

China

References

Li X, Xie J, Zhang L, Cui Y, Zhang G, Wang J, Zhang A, Chen X, Huang T, Meng Q. Differential distribution of manifest lesions in diabetic retinopathy by fundus fluorescein angiography and fundus photography. BMC Ophthalmol. 2020 Dec 1;20(1):471. doi: 10.1186/s12886-020-01740-2.

Reference Type: DERIVED

PMID: 33261573 (View on PubMed)

Other Identifiers

2018188H

Identifier Type: -

Identifier Source: org_study_id