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

Not Applicable

• Conditions: Diabetes Mellitus; Diabetic Retinopathy; Nerve Injury
• Interventions: Device: routine ophthalmic examination

• Registration Number: NCT03970161
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-22
• Study Start: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Last Update Submitted: 2019-05-29
• Study First Posted: 2019-05-31
• Last Update Posted: 2019-05-31
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

1. Patients with T2DM
2. Patients without microangioma

Exclusion Criteria

1. Patients with any other ocular disease that might affect retinal nerve injury
2. Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion.
3. Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes.
4. Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T2DM Patients	routine ophthalmic examination	Patients without microangioma changes undergoing FFA examination were included in the present study. All of the participants enrolled in the present study underwent a systematic ophthalmic examination.
healthy control subjects	routine ophthalmic examination	All of the participants enrolled in the present study underwent a systematic ophthalmic examination.

Primary Outcome Measures

Name	Time	Method
GCL+ in the macular area obtained using the 3D wide mode	96 weeks	GCL+ in the macular area obtained using the 3D wide mode
RNFL thickness in the macular area obtained using the 3D Macula (v) mode	96 weeks	RNFL thickness in the macular area obtained using the 3D Macula (v) mode
Peripapillary RNFL thickness	96 weeks	Peripapillary RNFL thickness
Retinal thickness in all macular regions	96 weeks	Retinal thickness in all macular regions
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode	96 weeks	GCL+ thickness in the macular region obtained using the 3D Macula (v) mode

Trial Locations

Locations (1)

The third affiliated hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China