|- candidate number||5628|
|- NTR Number||NTR1765|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-apr-2009|
|- Secondary IDs||09-027 METC UMCU|
|- Public Title||Detection of infection with SELDI-tof in case of endophthalmitis.|
|- Scientific Title||Determination of protein profiles in vitreous of eyes with endophthalmitis with Surface Enhanced Laser desorption/ ionization time-of-flight (SELDI-tof) technology.|
|- hypothesis||Technology in determination of disease-specific protein profiles of bacteria in vitreous of patients with endophthalmitis after cataract surgery.
Protein profiles of vitreous samples from endophthalmitis patients with a negative culture will be compared to those from patients in which the bacterial cause is identified. |
|- Healt Condition(s) or Problem(s) studied||Endophthalmitis, Macular pucker, Macular hole|
|- Inclusion criteria||Patients with endophthalmitis: |
1. Able to give informed consent;
2. Age > 18 years;
3. Initiation of endophthalmitis within 6 weeks after cataract surgery.
1. Able to give informed consent;
2. Age > 18 years;
3. Patient that undergo a pars plana vitrectomy because of a macular hole or macular pucker.
|- Exclusion criteria||Endophthalmitis group:|
1. Patients unable to give informed consent;
2. Previous uveitis in the affected eye;
3. Previous pars plana vitrectomy in the affected eye.
1. Macylar hole/ macular pucker;
2. Patients unable to give informed consent;
3. Retinopathy because of Diabetes Mellitus or previous uveitis in the affected eye;
4. Previous pars plana vitrectomy in the affected eye.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mei-2009|
|- planned closingdate||1-mei-2010|
|- Target number of participants||110|
|- Interventions||All patients (treatment and control) will undergo vitreous biopsy for this study to collect vitreous for analyses with SELDI-tof.
0.1 ml vitreous will be kept and frozen at -80 degrees Celsius. Additionally, of 10 patients in each group a blood sample will be drawn. After centrifuging the blood, serum will be aspirated and frozen at -80 degrees Celsius. Both serum and vitreous will be used for analyses with SELDI-tof.
|- Primary outcome||Three analyses will be performed with SELDI-tof in comparison to regular culture methods:|
1. Comparison of protein composition of vitreous in comparison to serum obtained bij surgery for maucular hole or
macular pucker: controll population;
2. Comparison of protein composition of vitreous in comparison to serum of patients with endophthalmtis;
3. Comparison of protein composition of vitreous in comparison to serum of patients with endophthalmitis versus
the controll population.
|- Secondary outcome||1. Evaluation of the correlation between specific bacterial causes of endophthalmitis indentified by culture and
specific protein pattern obtained via SELDI-tof analyses;|
2. Evaluation of the correlation of vitreous of endophthalmitis with a negative result with culture and the protein
pattern obtained by SELDI-tof analyses.
We will compare the protein patterns of culture negative results with
peak pattern of bacteriae identified by culture.
|- Timepoints||Analyses with SELDI-tof wil take place after all samples are collected.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. C. Bennebroek|
|- CONTACT for SCIENTIFIC QUERIES||MD. C. Bennebroek|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Dr. F.P. Fischer Stichting|
|- Brief summary||Background:|
SELDI-tof analyses protein content in body fluids. This technique is extremely suitable for microvolumia, since only 1 microlitre is required for analysis. Biomarkers or bacterial-specific biomarkers can be identified by comparing profiles of different patient groups (endophthalmitis versus controls).
In this study, SELDI-tof technology is used as a new diagnostic test in ocular inflammation based on infection.
All material will be collected in the Netherlands.
The group with infection exists of 50 patients with endophthalmitis developed within 6 weeks after cataract surgery. Treatment of this disease exists of retro bulbar anaesthesia followed by a vitreous biopsy (0.2-0.3 ml) with a vitrectome. After biopsy broad spectral antibiotics are injected in the vitreous cavity. The vitreous biopsy is sent for microbiological culture.
The control group will exist of 2 subgroups: 30 patients who will be operated because of a macular hole and 30 patients who will be operated because of a macular pucker. Surgery, a pars plana vitrectomy, will be performed with retro bulbar or general anaesthesia. In both cases surgical treatment starts with aspiration of the vitreous before treatment of the macula.
In this study in each subgroup 0.1 ml vitreous will be separated from biopsy and frozen at -80 degrees Celsius. Additionally, of 10 patients in all subgroups a blood sample will be drawn. After centrifuging the blood, serum will be collected and frozen at -80 degrees Celsius for analyses with SELDI-tof
The SELDI-tof equipment is situated at the department of Virology in the University Medical Center Utrecht. A very small amount of vitreous and serum will be spotted on a NP 20 biochip.
SELDI-tof Biomarker Analysis Module, Expression Difference Mapping (EDM) analysis and Cluster Wizard (Ciphergen Express Software 3.0) are used for statistical analysis of the peak patterns. With EDM the results of multiple experiments are statistically analysed for existence of possible biomarkers. With Cluster Wizard peaks can be clustered: a cluster is a group of peaks with equal mass on the same array. Statistic significance is reached when P < 0.05.
Differences in protein peaks will be analysed between serum and vitreous of endophthalmitis and the controll groups. Additionally differences in protein profiles among different bacterial causes of endophthalmitis will be analysed.
|- Main changes (audit trail)|
|- RECORD||19-apr-2009 - 23-sep-2009|