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Immediate Registration of photocoagulation lesions by slit-lamp adapted optical coherence tomography

Organizational Data

DRKS-ID:
DRKS00009350
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2015-10-21
Last update in DRKS:
2015-10-21
Registration type:
Retrospective

Acronym/abbreviation of the study

SoPhoS

URL of the study

No Entry

Brief summary in lay language

The SoPhoS study investigates fine tissue effects of retinal photocoagulation. It applies a customized machine for optical coherence tomography (OCT). In retinal photocoagulation, 1/50 - 1/5 s short, very intense laser irradations generate fine retinal burns, which are helpful in ischemic retinal diseases such as diabetic retinopathy to protect the eye from consecutive secondary diseases. The customized OCT-machine can record highly resolved sectional images of the coagulating retina in high speed, with hundreds of Frames per second. It also allows conclusions about temperature profiles and Perfusion within the tissue. We can recrute Patient eyes that receive panretinal laser photocoagulation for the first time and that are legally capable to give informed consent (above 18 years old, no prisoners), that are not pregnant and are physically without obstacles for the Treatment. Follow up examinations with clinical Standard Imaging will be necessary after 1 day, 1 and 3 months.

Brief summary in scientific language

The SoPhoS study applies Phase sensitive high-speed OCT to record representative Images of retina and choroid under laser irradatiation. It does not only generate morphological Information via OCT reflecitivity, but also allows conclusions about retinal and choroidal Perfusion, tissue displacement and temperature profiles. Functionality of the method in humans is to be tested, and first conclusions about the clinical potential of the method are to be drawn.

Health condition or problem studied

ICD10:
H36.0 - Diabetic retinopathy
ICD10:
H34.8 - Other retinal vascular occlusions
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Patients with indication for first session of panretinal laserphotocoagulation: Recording with high-speed OCT during application of 40 photocoagulation lesions, afterward clinical imaging of these lesions with OCT and color fundus photo over 3 months.

Endpoints

Primary outcome:
Histologic tissue changes under retinal photocoagulation
Secondary outcome:
data quality of custom made high-speed OCT

Study Design

Purpose:
Basic research/physiological study
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
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 Kiel

Recruitment period and number of participants

Planned study start date:
2015-09-15
Actual study start date:
2015-09-15
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
20
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
indication for panretinal photocoagulation, first treatment session

Exclusion Criteria

pregnancy disseases that hamper photocoagulation (Tremor, Nystagmus, spine Deformation), corneal diseases

Addresses

Primary Sponsor

Universitätsklinikum Schleswig-Holstein Campus Kiel
Arnold-Heller-Str. 3
24105 Kiel
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uk-sh.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für AugenheilkundeUniversitätsklinikum Schleswig-HolsteinCampus Kiel
PD Dr. med. Stefan Koinzer
Arnold-Heller-Str. 3, Haus 25
24105 Kiel
Germany
Telephone:
(04 31) 5 97 - 46 97
Fax:
(04 31) 5 97 - 24 28q
Contact per E-Mail
URL:
http://www.uni-kiel.de/uak

Contact for Public Queries

Klinik für AugenheilkundeUniversitätsklinikum Schleswig-HolsteinCampus Kiel
PD Dr. med. Stefan Koinzer
Arnold-Heller-Str. 3, Haus 25
24105 Kiel
Germany
Telephone:
(04 31) 5 97 - 46 97
Fax:
(04 31) 5 97 - 24 28q
Contact per E-Mail
URL:
http://www.uni-kiel.de/uak

Principal Investigator

Klinik für AugenheilkundeUniversitätsklinikum Schleswig-HolsteinCampus Kiel
PD Dr. med. Stefan Koinzer
Arnold-Heller-Str. 3, Haus 25
24105 Kiel
Germany
Telephone:
(04 31) 5 97 - 46 97
Fax:
(04 31) 5 97 - 24 28q
Contact per E-Mail
URL:
http://www.uni-kiel.de/uak

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.)

Bundesministerium für Bildung und Forschung Dienstsitz Berlin
Friedrichstraße 130 B
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bmbf.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Medizinischen Fakultät der Christian-Albrechts-Universität zu Kiel
Schwanenweg 20
24105 Kiel
Germany
Telephone:
+49-431-50014191
Fax:
+49-431-50014195
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2015-02-10
Ethics committee number:
D470/15
Vote of the Ethics Committee:
Approved
Date of the vote:
2015-06-01

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED 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:
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Other study documents:
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Background literature:
Darstellung der analog zur Patientenstudie durchgeführten Tierversuche
Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry