skin autofluorescence is a predictor of treatment responsiveness in patients who underwent vitrectomy because of PDR
ID
Bron
Verkorte titel
Aandoening
diabetes mellitus, diabetic retinopathy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
the relation between skin AF and visual outcome of PDR patients at 1 year after vitrectomy.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
skin autofluorescence is a predictor of treatment responsiveness in patients who underwent vitrectomy because of PDR
Onderzoeksopzet
baseline, 1 year
Onderzoeksproduct en/of interventie
skin autofluorescence measurement (non invasive)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8793 |
| Ander register | METC UMCG : METC 2020/350 |