The detection of intravitreal opsin concentrations in human eyes suffering from different alterations of the vitreomacular interface.
Organizational Data
- DRKS-ID:
- DRKS00007106
- Recruitment Status:
- Recruiting withdrawn (before recruiting started)
- Date of registration in DRKS:
- 2014-10-31
- Last update in DRKS:
- 2015-11-23
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Patients enrolled into this study will receive a pars plana vitrectomy. Vitreous specimen will be collected at the beginning of the procedure. Vitreous taps will be analyzed in regard to opsin concentrations in different diseases of the retina and the vitreoretinal border. The aim of the study is to evaluate a new parameter to classify retinal damage in various retinal diseases.
Brief summary in scientific language
The aim of the study is to detect intravitreal opsin concentrations in eyes suffering from different alterations of the vitreomacular interface and to clarify if different opsin concentrations are elevated in different vitreoretinal diseases and if specific opsin patterns are related to different vitreoretinal alterations. It is supposed that intravitreal opsin concentrations may rise in analogy to photoreceptor damage. If this study can proof this hypothesis there might be a new and the first biochemical marker to demonstrate the severity of retinal damage and probably for the prognosis for the diseaes analyzed like troponin I for myocardial infarction or creatinine for kidney disease.
Health condition or problem studied
- ICD10:
- H35.3 - Degeneration of macula and posterior pole
- ICD10:
- H33.0 - Retinal detachment with retinal break
- ICD10:
- H43.3 - Other vitreous opacities
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- retinal diseases inclusing: epiretinal membrane macular hole retinal detachment diabetic macular edema wet age-related macular degeneration retinal vein occlusion. Patients enrolled into this study will receive a pars plana vitrectomy. Vitreous specimen will be collected at the beginning of the procedure. Vitreous taps will be analyzed in regard to opsin concentrations in different diseases of the retina and the vitreoretinal border.
- Arm 2:
- vitreous floater as control Group (all retinal diseases excluded)
Endpoints
- Primary outcome:
- Intravitreal opsin concentrations in different alterations of the vitreomacular Interface as measured with cytometric bead assay (CBA). Analysis will be performed within 6 months after sampling vitreous specimen. Comparison of intravitreal opsin concentrations among the different retinal diseases and between the retinal diseases and the controll Group (vitreous floater without any acommpanying retinal disease).
- Secondary outcome:
- none
Study Design
- Purpose:
- Diagnostic
- Allocation:
- Non-randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting withdrawn (before recruiting started)
- Reason if recruiting stopped or withdrawn:
- Lack of funding
Recruitment Locations
- Recruitment countries:
-
- Austria
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Augenklinik Marburg
- Medical center Augenklinik Bürgerhospital Frankfurt
- University medical center Augenklinik Marburg
- Medical center Augenklinik Bürgerhospital Frankfurt
- University medical center Augenklinik Heidelberg
- Medical center Augenklinik Feldkirch
- Medical center Augenklinik Marienshospital Düsseldorf
Recruitment period and number of participants
- Planned study start date:
- 2015-07-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 350
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 100 Years
- Additional Inclusion Criteria:
- H35.3 Degeneration of the macula and posterior pole H33.0 rhegmatogenous retinal detachment H43.3 vitreous floater patients are included who will receive a pars plana vitrectomy routinely with following diseases: epiretinal membrane, macular hole, retinal detachment, diabetic macular edema, wet age-related macular degeneration, retinal vein occlusion
Exclusion Criteria
vitrectomized eyes former intravitreal anti-VEGF or steroid injections former focal or panretinal laser coagulation former retinal kryocoagulation former uveitis former buckle surgery
Addresses
Primary Sponsor
- Address:
- KKS MarburgKarl-von-Frisch-Straße 435043 MarburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.kks.uni-marburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Philipps-Universität MarburgAugenklinikDr. Thomas BertelmannBaldingerstraße35043 MarburgGermany
- Telephone:
- 06421-5861384
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukgm.de
Contact for Public Queries
- Address:
- Philipps-Universität MarburgAugenklinikDr. Thomas BertelmannBaldingerstraße35043 MarburgGermany
- Telephone:
- 06421-5861384
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukgm.de
Principal Investigator
- Address:
- Philipps-Universität MarburgAugenklinikDr. Thomas BertelmannBaldingerstraße35043 MarburgGermany
- Telephone:
- 06421-5861384
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukgm.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Augenklinik der Philipps-Universität MarburgBaldingerstraße35043 MarburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-marburg.de/fb20/augenklinik
Ethics Committee
Address Ethics Committee
- Address:
- Ethikommission Fachbereich Medizin der Philipps-Universität MarburgBaldingerstr. 135032 MarburgGermany
- Telephone:
- +49-6421-5866487
- Fax:
- +49-6421-5866585
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-06-11
- Ethics committee number:
- 94/09 und 117/10; Amendment 2 vom 18.06.2014
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-06-30
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry