Diabetic retinopathy
Conditions
Interventions
Healthy control group:None
Patients with proliferative diabetic retinopathy (PDR) scheduled to receive intravitreal injection combined with pars plana vitrectomy (PPV):None
Patients with proliferative diabetic retinopathy (PDR) undergoing pars plana vitrectomy (PPV) alone:None
Patients with non-proliferative diabetic retinopathy.:None
Diabetic individuals without diabetic retinopathy as controls.:None
Sponsors
The Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Normal Control Group Criteria: 1.Be able to understand and cooperate with subjective examinations, with no any ocular disease manifestations, no history of ocular surgery, and no systemic diseases affecting the ocular surface 2.Patients aged 18-80 years old 3.The subjects or their legal guardians voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up Criteria of the Experimental Group: 1.Diagnosis of diabetes by a qualified clinician. 2.Diabetic retinopathy stage determined by an experienced retina specialist according to the International Clinical Diabetic Retinopathy Disease Severity Scale published by the American Academy of Ophthalmology and the International Council of Ophthalmology in 2002. 3.Age 18–80 years. 4.Subject (or legally authorized representative) voluntarily consents to participate, signs the informed-consent form, is compliant, and agrees to attend follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Severe hepatic or renal insufficiency (especially creatinine clearance 3 months prior is allowed). 3.Corneal pathology such as corneal dystrophy, keratitis or pterygium. 4.Previous ocular trauma. 5.Active ocular inflammation. 6.Contact-lens wear within the last 6 months. 7.Diseases affecting corneal nerves (e.g. facial palsy, trigeminal-nerve injury, neurotrophic keratitis) or definite severe dry-eye disease. 8.Dry-eye treatment other than artificial tears (e.g. intense-pulsed-light therapy or punctal plugs). 9.Systemic disorders affecting the ocular surface (e.g. Sjögren syndrome, Stevens–Johnson syndrome). 10.Systemic neuropathies unrelated to diabetes (e.g. Guillain–Barré syndrome, SLE, Lyme disease, vasculitis). 11.Media opacity preventing retinal examination (dense cataract, vitreous opacity). 12.Pregnant or lactating women, or any fertile participant (male or female) planning pregnancy or unwilling to use effective contraception during the study. 13.Psychiatric or psychological illness. 14.Any systemic condition that, in the investigator’s opinion, makes participation unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal Nerve Fiber Length;corneal nerve sensitivity-test by non-contact corneal aesthesiometer (NCCA);Corneal Nerve Branching Density;Corneal Nerve Fiber Density;Corneal Terminal Branch Density;corneal nerve sensitivity-test by Cochet - Bonnet Aesthesiometer(CBA); | — |
Secondary
| Measure | Time frame |
|---|---|
| corneal fluorescein stating (NEI criteria);Grading of Nerve Curvature;Nerve Fibre Fractal Dimension (CFracDim); | — |
Countries
China
Contacts
Public ContactWei Chen
The Eye Hospital of Wenzhou Medical University
Outcome results
None listed