No registrations found.
ID
Source
Brief title
Health condition
Rhegmatogenous retinal detachment (RRD) is a sight-threatening condition, most often initiated by a posterior vitreous detachment-associated retinal tear. A recent study found an incidence of RRD in the Netherlands of 18.2 per 100,000 people.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Surgical failure
Secondary outcome
2. Skin autofluorescence
3. Vitreous body AGE levels
4. Vitreous body sRAGE levels
5. plasma sRAGE levels
6. Glyoxalase polymorphisms
7. RAGE polymorphisms
8. Age,
9. gender,
10. surface area of retinal detachment,
11. number of retinal defects,
12. macular detachment,
13. detachment duration,
14. pre-operative PVR grade,
15. presence of diabetes,
16. pseudophakia,
17. intraoperative use of gas or silicon oil,
18. intraoperative cryotherapy, intraoperative minor hemorrhage.
Background summary
The aim of this study is to investigate whether skin autofluorescence (AF) is predictive of postoperative PVR (and corresponding surgical failure) in patients being surgically treated for retinal detachment and to investigate some pathways which may contribute to the explanation of the relation of systemic skin AF with local eye disease.
The objectives will be tested in a prospective cohort study in patients who will undergo vitrectomy because of retinal detachment
Study objective
Advanced glycation endproducts (AGEs) may play a role in the development of PVR and hence surgical failure. Possibly, autofluorescence of AGEs in the skin, measured by the simple non-invasive AGE reader, could be used as a predictor for post-operative proliferative vitreoretinopathy and surgical failure in patients with retinal detachment.
Study design
1. Surgical failure - Re-detachment - Timepoint: 3 months
2. Skin autofluorescence - AGE reader MU - Timepoint: 0
Vitreous biopsy - timepoint: 0 - 14 days
3. Vitreous body AGE levels - high performance liquid chromatography (HPLC)- Timepoint: After inclusion of all patients.
4. Vitreous body sRAGE levels - Enzyme linked immunosorbent (ELISA) techniques - Timepoint: After inclusion of all patients.
5. plasma sRAGE levels - Enzyme linked immunosorbent (ELISA) techniques - Timepoint: After inclusion of all patients.
6. Glyoxalase polymorphisms - Genotyping techniques - Timepoint: After inclusion of all patients.
7. RAGE polymorphisms - Genotyping techniques - Timepoint: After inclusion of all patients.
8. Age - Timepoint:0
9. gender - Timepoint:0
10. surface area of retinal detachment - Timepoint: Vitreous biopsy
11. number of retinal defects - Timepoint: Vitreous biopsy
12. macular detachment - Timepoint: Vitreous biopsy
13. detachment duration - Timepoint: Vitreous biopsy
14. pre-operative PVR grade - Timepoint: Vitreous biopsy
15. presence of diabetes - Timepoint:0
16. pseudophakia - Timepoint: 0
17. intraoperative use of gas or silicon oil - Timepoint: Vitreous biopsy
18. intraoperative cryotherapy, intraoperative minor hemorrhage - Timepoint: Vitreous biopsy
Intervention
None
Department of Ophthalmology
P.O. Box 30.001
L.I. Los
Groningen 9700 RB
The Netherlands
+31 (0)50 3612510
l.i.los@ohk.umcg.nl
Department of Ophthalmology
P.O. Box 30.001
L.I. Los
Groningen 9700 RB
The Netherlands
+31 (0)50 3612510
l.i.los@ohk.umcg.nl
Inclusion criteria
1. Willingness to participate.
2. Patients, newly diagnosed with retinal detachment, scheduled for vitrectomy.
3. Age: >18 years.
Exclusion criteria
1. Dark coloured skin that impairs the reliability of the autofluorescence measurement.
2. Skin abnormalities on both arms that will impair the reliability of the autofluorescence measurement.
3. Local or general active infection or inflammatory disease.
4. Known renal disease with impairment of renal function class CKD ≥3 (≤ 60 ml/min according to eGFR), current dialysis treatment, or a history of renal transplantation.
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 |
|---|---|
| NTR-new | NL4145 |
| NTR-old | NTR4289 |
| Other | METc UMCG : METc 2013/153 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |