Correlation of subjective visual parameters with morphologic parameters in reactivation of exsudative maculopathies
Organizational Data
- DRKS-ID:
- DRKS00006851
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2014-10-09
- Last update in DRKS:
- 2014-10-21
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
Different exsudative diseases of the macula (e.g. age related maculopathy (AMD), diabetic macular edema (DME), macular edema in retinal vein occlusion (RVO), myopic choroidal neovascularisation (CNV)) are currently treated by intravitreal injection of VEGF inhibitors. The official recommendations of the german ophthalmological associations (DOG, BVA, RG) include that affected patients shall be controlled in monthly intervals after the end of treatment. These controls require a high logistic support for both patients and examiner (time, transport, devices). The aim of this study is to investigate wether subjective parameters (estimation of the visual acuity and the metamorphopsia) can help to detect reliably a reactivation of disease. For this purpose we plan to compare the current gold standard of clinical examination (visual acuity, morphologic examination with the optical coherence tomography (OCT)) with the above-named subjective parameters. We try to identify patient groups in which the control interval might be adapted. Different diseases (AMD, DME, RVO, myopic CNV) shall be analyzed. In a second step the correlation between subjecitve parameters and morphologic parameters shall be investigated.
Health condition or problem studied
- ICD10:
- H35.3 - Degeneration of macula and posterior pole
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- non-interventional study retrospective data analysis of all patients who were examined in the clinical "IVOM-OCT-consultation" (clinical control of the success of treatment about 8 weeks after the last intravitreal injection, 4 weeks after the first control of success). If several appointments in the "IVOM-OCT-consultation" have taken place only the first documented appointment will be analysed (analysis of the documented subjective estimation of visual acuity and metamorphopsia, analysis of the documented visual acuity, analysis of the executed OCT)
Endpoints
- Primary outcome:
- specificity and sensitivity of subjective parameter (e.g. visual acuity, metamorphopsia; evaluation of the subjective devolopment as defined by better / worse / equal) in the evaluation of activity of maculopathy in age related maculopathy, retinal vein occlusion, diabetic retinopathy and other maculopathies
- Secondary outcome:
- Differences in specificity and sensitivity of the above-named parameter in different diseases, identification of characteristics of the morphology in reactivated disease, correlation of these characteristics with subjective parameter, correlation with basic data (eye function, age)
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Augenheilkunde Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- 2014-10-15
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 1200
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- first examination of patients with maculopathy (age related maculopathy, diabetes, retinal vein occlusion, myopia, other diseases with development of choroidal neovascularisation) having received intravitreal injections with anti-VEGF (bevacizumab, ranibizumab, aflibercept) who were adjudged to be not in need of further treatment and were appointed to control examinations in the "IVOM-OCT-Sprechstunde"
Exclusion Criteria
examination other than primary examination, other interventions (e.g. injection of TAC, Jetrea, Ozurdex), surgery of the study eye in the intervall between last intravitreal injection and OCT control
Addresses
Primary Sponsor
- Address:
- Klinik für AugenheilkundeUniversitätsklinikum FreiburgKillianstr. 579106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für AugenheilkundeUniversitätsklinikum FreiburgDr. Christoph EhlkenKillianstr. 579106 FreiburgGermany
- Telephone:
- 0761/270-40010
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinik für AugenheilkundeUniversitätsklinikum FreiburgDr. Christoph EhlkenKillianstr. 579106 FreiburgGermany
- Telephone:
- 0761/270-40010
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Klinik für AugenheilkundeUniversitätsklinikum FreiburgDr. Christoph EhlkenKillianstr. 579106 FreiburgGermany
- Telephone:
- 0761/270-40010
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für AugenheilkundeUniversitätsklinikum FreiburgKillianstr. 579106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- 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:
- 2014-08-20
- Ethics committee number:
- 413/14
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-09-23
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