UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022492
Receipt number R000025915
Scientific Title Observation of changes in ocular structural and functional parameters before and after steep Trendelenburg positioning during robotic-assisted laparoscopic radical prostatectomy (RALP)
Date of disclosure of the study information 2016/12/01
Last modified on 2016/05/27 14:00:00

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Basic information

Public title

Observation of changes in ocular structural and functional parameters before and after steep Trendelenburg positioning during robotic-assisted laparoscopic radical prostatectomy (RALP)

Acronym

Ocular parameter change after RALP

Scientific Title

Observation of changes in ocular structural and functional parameters before and after steep Trendelenburg positioning during robotic-assisted laparoscopic radical prostatectomy (RALP)

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Masahiro Zako

Organization

Aichi Medical University

Division name

Department of Ophthalmology

Zip code


Address

1-1 Karimata, Yazako, Nagakute, Aichi

TEL

0561623311

Email

Mzako@aol.com


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Zako

Organization

Aichi Medical University

Division name

Department of Ophthalmology

Zip code


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 or person

Institute

Department of Ophthalmology
Aichi Medical University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 07 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025915


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name