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

Sun Yat-sen University

Status: Unknown

Conditions: Diabetes Mellitus; Nerve Injury; Diabetic Retinopathy

Treatments: Device: routine ophthalmic examination

Study type: Interventional

Funder types: Other

Identifiers

NCT03970161

Retinal nerve injury in T2DM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 2 patient groups

T2DM Patients

Experimental group

Description:

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.

Treatment:

Device: routine ophthalmic examination

healthy control subjects

Experimental group

Description:

All of the participants enrolled in the present study underwent a systematic ophthalmic examination.

Treatment:

Device: routine ophthalmic examination