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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Diabetic Retinopathy, Nerve Injury

Intervention / Treatment
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* Device: routine ophthalmic examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with T2DM Patients without microangioma Exclusion Criteria: Patients with any other ocular disease that might affect retinal nerve injury Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion. Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes. Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T2DM Patients<br>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. | Device: routine ophthalmic examination<br>* 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.<br>|
| Experimental: healthy control subjects<br>All of the participants enrolled in the present study underwent a systematic ophthalmic examination. | Device: routine ophthalmic examination<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripapillary RNFL thickness | Peripapillary RNFL thickness | 96 weeks | 
| GCL+ in the macular area obtained using the 3D wide mode | GCL+ in the macular area obtained using the 3D wide mode | 96 weeks | 
| Retinal thickness in all macular regions | Retinal thickness in all macular regions | 96 weeks | 
| RNFL thickness in the macular area obtained using the 3D Macula (v) mode | RNFL thickness in the macular area obtained using the 3D Macula (v) mode | 96 weeks | 
| GCL+ thickness in the macular region obtained using the 3D Macula (v) mode | GCL+ thickness in the macular region obtained using the 3D Macula (v) mode | 96 weeks |