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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007106 |
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Date of registration:
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31/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The detection of intravitreal opsin concentrations in human eyes suffering from different alterations of the vitreomacular interface.
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Scientific title:
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The detection of intravitreal opsin concentrations in human eyes suffering from different alterations of the vitreomacular interface. |
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Date of first enrolment:
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01/07/2015 |
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Target sample size:
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350 |
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Recruitment status: |
Recruiting withdrawn before recruiting started |
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URL:
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http://drks.de/search/en/trial/DRKS00007106 |
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Study type:
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interventional |
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Study design:
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Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose: diagnostic
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Phase:
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N/A
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Countries of recruitment
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Austria
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Germany
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Contacts
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Name:
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Thomas
Bertelmann |
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Address:
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Baldingerstraße
35043
Marburg
Germany |
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Telephone:
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06421-5861384 |
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Email:
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thomas.bertelmann@staff.uni-marburg.de |
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Affiliation:
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Philipps-Universität MarburgAugenklinik |
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Name:
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Thomas
Bertelmann |
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Address:
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Baldingerstraße
35043
Marburg
Germany |
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Telephone:
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06421-5861384 |
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Email:
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thomas.bertelmann@staff.uni-marburg.de |
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Affiliation:
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Philipps-Universität MarburgAugenklinik |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Retinal detachment with retinal break
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H35.3
H33.0
H43.3
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H35.3
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H43.3
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H33.0
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Degeneration of macula and posterior pole
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Other vitreous opacities
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Intervention(s)
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Group 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.
Group 2: vitreous floater as control Group (all retinal diseases excluded)
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Primary Outcome(s)
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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).
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Source(s) of Monetary Support
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Augenklinik der Philipps-Universität Marburg
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Deutsche Forschungsgemeinschaft
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Ethics review
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Status: Approved
Approval date: 30/06/2014
Contact:
ethikkom@staff.uni-marburg.de
Ethikommission Fachbereich Medizin der Philipps-Universität Marburg
+49-6421-5866487
ethikkom@staff.uni-marburg.de
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