UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observation of changes in ocular structural and functional parameters before and after steep Trendelenburg positioning during robotic-assisted laparoscopic radical prostatectomy (RALP)
Title of the study (Brief title)	Ocular parameter change after RALP
Region	Japan

Condition
Condition	prostatic cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To measure perioperative intraocular pressure. To compare the thicknesses of the peripapillary retinal nerve fibre layer (RNFL), ganglion cell complex (GCC), and central foveal (CF) before and after RALP.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The thicknesses of the peripapillary RNFL, GCC, and CF measured with spectral domain optical coherence tomography. Humphrey perimetry was performed before, and 3 and 6 months after surgery.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Patients with prostatic cancer
Key exclusion criteria	Patients were excluded if they had pre-existing glaucoma and retinal vascular diseases that may affect neuroretinal function or corneal diseases that may affect the IOP measurement.
Target sample size	20

Research contact person
Name of lead principal investigator	Masahiro Zako
Organization	Aichi Medical University
Division name	Department of Ophthalmology
Address	1-1 Karimata, Yazako, Nagakute, Aichi
TEL	0561623311
Email	Mzako@aol.com

Public contact
Name of contact person	Masahiro Zako
Organization	Aichi Medical University
Division name	Department of Ophthalmology
Address	1-1 Karimata, Yazako, Nagakute, Aichi
TEL	0561623311
Homepage URL	http://www.aichi-med-u.ac.jp/su06/su0611/su061100/__icsFiles/afieldfile/2013/05/29/rin_H25-02.pdf
Email	Mzako@aol.com

Sponsor
Institute	Department of Ophthalmology Aichi Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	愛知医科大学病院（愛知県）/Aichi Medical University Hospital (Aichi Prefecture)

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 01 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2013 Year 07 Month 31 Day
Date of closure to data entry	2014 Year 01 Month 31 Day
Date trial data considered complete	2014 Year 07 Month 01 Day
Date analysis concluded	2015 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The mean visual acuity (logarithm of the minimal angle of resolution), IOP, mean deviation, and pattern standard deviation measured by the Humphrey field analyser showed no statistically significant difference before and after surgery.

Management information
Registered date	2016 Year 05 Month 27 Day
Last modified on	2016 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025915