Diabetes Mellitus, Diabetic Retinopathy, Nerve Injury
Conditions
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.
Interventions
DEVICEroutine 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.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripapillary RNFL thickness | 96 weeks | Peripapillary RNFL thickness |
| GCL+ in the macular area obtained using the 3D wide mode | 96 weeks | GCL+ in the macular area obtained using the 3D wide mode |
| Retinal thickness in all macular regions | 96 weeks | Retinal thickness in all macular regions |
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactXiang Zhu
Outcome results
None listed