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
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
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
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
