The aim of this study is to investigate whether the risk and severityof retinal detachment are related to skin autofluorescence (AF).
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: the relation between skin AF,vitreous body AGE levels, and
plasma AGE levels.
Secondary outcome
Secondary endpoint: relation between vitreous body AGE levels and severity of
retinal detachment.
Other study parameters: verbally asked questions about cardiovascular history,
concomitant disease and medication, and current and previous smoking habits
Background summary
With aging, structural changes develop in the vitreous body. This can be
followed by the development of a posterior vitreous detachment, which can
induce retinal damage such as intravitreal hemorrhage, retinal tear and retinal
detachment.
The importance of collagen fibrils in maintaining the vitreous gel structure
leads to the logical assumption that changes in the gel structure could be
directly related to changes in the collagen fibrils. These changes can be
caused by forming advanced glycation endproducts (AGEs), which involves a
series of non-enzymatic reactions with reducing sugars, oxoaldehydes, oxidized
lipids and reactive carbonyls. AGEs form arbitrarily on any protein, dependent
on the concentration of reactive molecules, and, once settled, they can only be
removed by degradation of the protein.
Recently, it has been suggested that AGEs may be involved in vitreo-retinal
interface diseases. . It would be clinically interesting to find out whether
AGE content in the vitreous body is a predictor of risk of retinal detachment.
However, only invasive techniques for assessing AGE content of the vitreous
body are available. This is not appropriate to function as a predictor. Plasma
or serum AGE assays may be used, but these are often not representative for the
actual accumulation of AGE in tissue.
A possible solution is the use of skin autofluorescence, measured by an AGE
reader. The AGE reader has been validated on skin biopsy levels of pentosidine,
carboxymethyllysine (CML) and carboxyethyllysine (CEL) in several patient
groups and healthy persons. Skin autofluorescence might also correlate with AGE
accumulation in the vitreous body.
Study objective
The aim of this study is to investigate whether the risk and severityof retinal
detachment are related to skin autofluorescence (AF).
Study design
The study will potentialy consist of three phases:
1. First, in a pilot study the presumed relation between skin AF and vitreous
body AGE levels will be tested in post-vitrectomy patients with known levels of
AGEs in the vitreous body. Skin AF and blood sampling will be performed in
patients.
2. Second, if the relation of skin AF to vitreous body AGE levels is confirmed
in the pilot study, this relation will be tested cross-sectionally in patients
who undergo vitrectomy because of retinal detachment
Optionally 3. Third, if there is some evidence found to assume that skin AF is
an early predictor of the risk and severity of retinal detachment, we intend to
write a subsequent protocol to investigate this further in a follow-up study.
This part is not yet included in the present METC submission.
Study burden and risks
none, except those of single i.v. blood drawing
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
• Willingness to participate.
• (Post-) vitrectomy patients, previously diagnosed with retinal detachment.
• Age: >18 years.
Exclusion criteria
• Unwillingness to participate.
• Dark coloured skin (Fitzpatrick type V or VI).
• 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.;Exclusion criteria only for the pilot study
• Known diabetes mellitus.
• Pre-existing cardio-vascular complications
• Intra-ocular implant lens.
Design
Recruitment
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 |
|---|---|
| CCMO | NL37322.042.11 |