NCT03970161

Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The object of this study is to investigate the damage to the retinal nerve fiber layer (RNFL) and ganglion cell complex layer (GCL+) in diabetic patients without retinal microangioma as detected by fundus fluorescein angiography (FFA) and to determine the kind of nerve damage more likely to indicate early injury.

Detailed description

Patients with type 2 diabetes mellitus and healthy volunteers will be included in our study. Patients with retinal microangioma are excluded by FFA. The parameters around the optic disc and macular area of the above two groups are measured by optical coherence tomography (OCT), and the results will be analyzed using the SPSS 22.0 software.

Conditions

• Diabetes Mellitus
• Diabetic Retinopathy
• Nerve Injury

Interventions

Type	Name	Description
DEVICE	routine ophthalmic examination	Routine ophthalmic examination, including slit lamp, intraocular pressure, and fundus examinations using direct or indirect ophthalmoscopy after pupil dilation and optical coherence tomography (OCT) examination. Patients with DM also underwent fundus fluorescein angiography (FFA) examination.

Timeline

• Start date: 2019-05-29
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-05-31
• Last updated: 2019-05-31

Locations

1 site across 1 country: China