Trial document

PLEASE NOTE:
This trial has been registered retrospectively.

drksid header

DRKS-ID: DRKS00008890

Trial Description

start of 1:1-Block title

Title

corneal densitometry in patients Amiodaron induced keratopathy

end of 1:1-Block title

start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym

start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url

start of 1:1-Block public summary

Brief Summary in Lay Language

aims to evaluate the effect of ammiodaron on the corneal trancparency

end of 1:1-Block public summary

start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

to evaluate the effect of ammiodaron Keratopathy on the corneal densitometry

end of 1:1-Block scientific synopsis

start of 1:1-Block organizational data

Organizational Data

DRKS-ID: DRKS00008890
Date of Registration in DRKS: 2015/07/14
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 2015-115-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster

end of 1:1-Block organizational data

start of 1:n-Block secondary IDs

Secondary IDs

[---]*

end of 1:n-Block secondary IDs

start of 1:N-Block indications

Health Condition or Problem studied

ICD10: H18.9 - Disorder of cornea, unspecified

end of 1:N-Block indications

start of 1:N-Block interventions

Interventions/Observational Groups

Arm 1: In Patients under Amiodaron Treatment , we measure the densitometrie with the Pentacam ´(occulus Pentacam)

end of 1:N-Block interventions

start of 1:1-Block design

Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Screening
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

end of 1:1-Block design

start of 1:1-Block primary endpoint

Primary Outcome

corneal densitometry
The präsens of corneal deposits

end of 1:1-Block primary endpoint

start of 1:1-Block secondary endpoint

Secondary Outcome

correlation with Treatment duration and dose

end of 1:1-Block secondary endpoint

start of 1:n-Block recruitment countries

Countries of Recruitment

DE: Germany

end of 1:n-Block recruitment countries

start of 1:n-Block recruitment locations

Locations of Recruitment

University Medical Center Klinik für Augenheilkunde, Münster

end of 1:n-Block recruitment locations

start of 1:1-Block recruitment

Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2015/06/03
Target Sample Size: 100
Monocenter/Multicenter trial: Monocenter trial
National/International: National

end of 1:1-Block recruitment

start of 1:1-Block inclusion criteria

Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 80 Years

end of 1:1-Block inclusion criteria

start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

adult,
Ammiodaron Treatment

end of 1:1-Block inclusion criteria add

start of 1:1-Block exclusion criteria

Exclusion Criteria

history of corneal disease
pregnancy
renal or liver disease

end of 1:1-Block exclusion criteria

start of 1:n-Block addresses

Addresses

Primary Sponsor
start of 1:1-Block address primary-sponsor
- Universitäts-Augenklinik Münster
- Domagkstr. 15
- 48149 münster
- Germany
end of 1:1-Block address primary-sponsor

start of 1:1-Block address contact primary-sponsor
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
end of 1:1-Block address contact primary-sponsor
Contact for Scientific Queries
start of 1:1-Block address scientific-contact
- Universitäts-Augenklinik Münster
- Mr. Dr. Maged Alnawaiseh
- Domagkstr. 15 , 48149 Münster , Germany
- 48149 münster
- Germany
end of 1:1-Block address scientific-contact

start of 1:1-Block address contact scientific-contact
- Telephone: 02518356001
- Fax: [---]*
- E-mail: maged.alnawaiseh at ukmuenster.de
- URL: [---]*
end of 1:1-Block address contact scientific-contact
Contact for Public Queries
start of 1:1-Block address public-contact
- Universitäts-Augenklinik Münster
- Mr. Dr. Maged Alnawaiseh
- Domagkstr. 15 , 48149 Münster , Germany
- 48149 münster
- Germany
end of 1:1-Block address public-contact

start of 1:1-Block address contact public-contact
- Telephone: 02518356001
- Fax: [---]*
- E-mail: maged.alnawaiseh at ukmuenster.de
- URL: [---]*
end of 1:1-Block address contact public-contact

end of 1:n-Block addresses

start of 1:n-Block material support

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
start of 1:1-Block address materialSupport
- Universitäts-Augenklinik Münster
- Ms. Prof. Nicole Eter
- Domagkstr. 15
- 48149 Münster
- Germany
end of 1:1-Block address materialSupport

start of 1:1-Block address contact materialSupport
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
end of 1:1-Block address contact materialSupport

end of 1:n-Block material support

start of 1:1-Block state

Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

end of 1:1-Block state

start of 1:n-Block publications

Trial Publications, Results and other Documents

[---]*

end of 1:n-Block publications

* This entry means the parameter is not applicable or has not been set.