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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2DM Patients | Experimental | 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 | Experimental | All of the participants enrolled in the present study underwent a systematic ophthalmic examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| routine ophthalmic examination | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Zhu | Contact | 13826452564 | 0628zhuxiang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiang Zhu, Dorctor | Third Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The third affiliated hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |