An interventional study of routine ophthalmic examination in Diabetes Mellitus, Diabetic Retinopathy and Nerve Injury, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-31.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Prevention
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.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 720 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
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
All of the participants enrolled in the present study underwent a systematic ophthalmic examination.
Device: routine 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.
Peripapillary RNFL thickness
Peripapillary RNFL thickness
Time frame: 96 weeks
GCL+ in the macular area obtained using the 3D wide mode
GCL+ in the macular area obtained using the 3D wide mode
Time frame: 96 weeks
Retinal thickness in all macular regions
Retinal thickness in all macular regions
Time frame: 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
Time frame: 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
Time frame: 96 weeks
Plan to share: No
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This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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