No registrations found.
ID
Source
Brief title
Health condition
diabetes mellitus, diabetic retinopathy
Sponsors and support
Intervention
Outcome measures
Primary outcome
the relation between skin AF and visual outcome of PDR patients at 1 year after vitrectomy.
Secondary outcome
re-vitrectomy rate within the first year.
Background summary
Rationale
Proliferative diabetic retinopathy (PDR) is one of the major causes of blindness in diabetic patients. Currently, the main treatment options of PDR are panretinal laser coagulation and vitrectomy surgery. However, the treatment outcome is unsatisfactory. Although a majority of patients have improved visual acuity after surgery, they cannot regain sufficient vision for daily life.
Advanced glycation endproducts (AGEs) are protein bound compounds derived from glycemic and oxidative stress with fluorescent properties. AGEs are thought to play an important role in the pathogenesis of DR by binding to the receptor for AGEs, which leads to endothelial dysfunction, microglia activation, breakdown of the blood-retinal barrier, and upregulation of toxic cytokines. AGEs can be assessed non-invasively with skin autofluorescence (SAF), which make it a potential biomarker for diabetic screening. SAF and AGEs were reported to be correlated with the chance of developing type 2 diabetes mellitus, and AGEs with the severity of DR, and to have better predictive ability than hemoglobin A1c.
Objective
The aim of this study is to investigate the relationship between AGEs and treatment outcome to vitrectomy in PDR patients.
Study design
This study is a cross-sectional cohort study.
Study population
In this study, patients who have been diagnosed with PDR and have been or will be treated according to current guidelines with vitrectomy in the department of ophthalmology at the UMCG will be investigated
Intervention (if applicable)
Pars plana vitrectomy, with or without cataract extraction, with or without pre-operative laser treatment or anti-VEGF injection
Main study parameters/endpoints
Primary endpoint: the relation between skin AF and visual outcome of PDR patients at 1 year after vitrectomy.
Secondary endpoint: re-vitrectomy rate within the first year.
Study objective
skin autofluorescence is a predictor of treatment responsiveness in patients who underwent vitrectomy because of PDR
Study design
baseline, 1 year
Intervention
skin autofluorescence measurement (non invasive)
Inclusion criteria
• Willingness to participate.
• Age: >18 years.
• Patients diagnosed with PDR who have undergone or will undergo vitrectomy at the UMCG.
• Patients who have at least 1-year follow-up with BCVA after vitrectomy at the UMCG will be included.
Exclusion criteria
• Unwillingness to participate.
• Dark coloured skin (Fitzpatrick type V or VI), which will impair the reliability of the autofluorescence measurement.
• Skin abnormalities on both arms that will impair the reliability of the autofluorescence measurement.
• Local or general active infection or inflammatory disease.
• Known renal disease, current dialysis treatment, or a history of renal transplantation.
• Patients with high myopia (>6 diopters), glaucoma, combined retinal disease, prior vitreoretinal surgery.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8793 |
| Other | METC UMCG : METC 2020/350 |