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Temperature-controlled continous wave (cw)-laser treatment for CSR patients (TempLaser)

Organizational Data

DRKS-ID:
DRKS00028581
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2022-03-22
Last update in DRKS:
2022-04-04
Registration type:
Prospective

Acronym/abbreviation of the study

TempLaser

URL of the study

No Entry

Brief summary in lay language

Patients with chronic central serous retinopathy receive a temperature-controlled laser treatment that is based on real-time measurement and control and is intended to prevent unnecessary damage to the retina. The study aims to show that the new laser system works safely and reliably and that the disease improves after treatment. The new laser system is faster, more independent and cheaper than photodynamic therapy, which is currently not covered by health insurance.

Brief summary in scientific language

phase II clinical trial

Health condition or problem studied

ICD10:
H35.7 - Separation of retinal layers
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Patients with chronic retinopathy centralis serosa are treated with a CE-certified cw laser. One laser treatment (approx. 10-15min) was carried out in this study. A new module is coupled between the laser and the patient. It measures the real-time temperature on the retina and attenuates the energy to maintain a preset target temperature. The module can only throttle power. Temperature data and power curves can then be extracted and analyzed. Using image diagnostics (OCT, FAG, fundus photo), microperimetry and electrophysiology, therapy safety and success are checked in a 3-month follow-up.

Endpoints

Primary outcome:
Therapy safety controlled by: - Microperimetry - mERG - Optical coherence tomography - Fluorescence angiography - Fundus photography
Secondary outcome:
Therapy success controlled by: - Optical coherence tomography - Subjective improvement (analogue scale)

Study Design

Purpose:
Other
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
II
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
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Reason if recruiting stopped or withdrawn: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 Klinikum für Ophthalmologie am Universitätsklinikum Schleswig-Holstein, Campus Kiel Kiel

Recruitment period and number of participants

Planned study start date:
2022-03-29
Actual study start date:
2022-03-29
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
10
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- of legal age - central serous retinopathy for more than 3 months - Leackage point at least 500µm outside the fovea

Exclusion Criteria

- underage - Initial RCS diagnosis less than 3 months - Leackage point <500µm away from the fovea

Addresses

Primary Sponsor

Klinik für Ophthalmologie Universitätsklinikum Schleswig-Holstein Campus Kiel
Prof. Dr. Johann B. Roider
Haus B2, Arnold-Heller-Straße 3
24105 Kiel
Germany
Telephone:
0431 500 24202
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uksh.de/augenklinik-kiel
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Klinik für Ophthalmologie Universitätsklinikum Schleswig-Holstein Campus Kiel
Dr. med. Claus von der Burchard
Haus B2, Arnold-Heller-Straße 3
24105 Kiel
Germany
Telephone:
0431 500 24202
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uksh.de/augenklinik-kiel

Contact for Public Queries

Klinik für Ophthalmologie Universitätsklinikum Schleswig-Holstein Campus Kiel
Dr. med. Claus von der Burchard
Haus B2, Arnold-Heller-Straße 3
24105 Kiel
Germany
Telephone:
0431 500 24202
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uksh.de/augenklinik-kiel

Principal Investigator

Klinik für Ophthalmologie Universitätsklinikum Schleswig-Holstein Campus Kiel
Dr. med. Claus von der Burchard
Haus B2, Arnold-Heller-Straße 3
24105 Kiel
Germany
Telephone:
0431 500 24202
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uksh.de/augenklinik-kiel

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:
2021-03-31
Ethics committee number:
D 484/21
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-05-10

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
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