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Skin autofluorescence and surgical failure in retinal detachment patients


- candidate number15775
- NTR NumberNTR4289
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-nov-2013
- Secondary IDsMETc 2013/153 METc UMCG
- Public TitleSkin autofluorescence and surgical failure in retinal detachment patients
- Scientific TitleThe role of skin autofluorescence as a predictor for post-operative proliferative vitreoretinopathy and surgical failure in patients with retinal detachment
- ACRONYM-
- hypothesisAdvanced 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.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. Willingness to participate.
2. Patients, newly diagnosed with retinal detachment, scheduled for vitrectomy.
3. Age: >18 years.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 11-nov-2013
- planned closingdate
- Target number of participants500
- InterventionsNone
- Primary outcome1. Surgical failure
- Secondary outcome2. 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.
- Timepoints1. 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
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. L.I. Los
- CONTACT for SCIENTIFIC QUERIESDr. L.I. Los
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThe 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
- Main changes (audit trail)
- RECORD27-nov-2013 - 29-mei-2016


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