UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033012 |
|---|---|
| Receipt number | R000037634 |
| Scientific Title | The pharmacological mydriatic pupil-to-limbal diameter ratio as a intuitive predictor for the risk of intraoperative floppy iris syndrome |
| Date of disclosure of the study information | 2018/06/15 |
| Last modified on | 2020/06/22 22:48:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The pharmacological mydriatic pupil-to-limbal diameter ratio as a intuitive predictor for the risk of intraoperative floppy iris syndrome
Acronym
Pupil/limbal ratio predicts IFIS
Scientific Title
The pharmacological mydriatic pupil-to-limbal diameter ratio as a intuitive predictor for the risk of intraoperative floppy iris syndrome
Scientific Title:Acronym
Pupil/limbal ratio predicts IFIS
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To predict development of intraoperative floppy iris syndrome (IFIS) using the preoperative pharmacologically dilated PL ratio
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of IFIS
Key secondary outcomes
Preoperative pupil diameter, pupil-to-limbal diameter ratio and intuitive pupil-to-limbal diameter ratio
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1)Male patients who were taking alpha1-ARAs at the time of cataract surgery
2)only one eye for a case
Key exclusion criteria
Previous eye surgery, traumatic cataract, and zonulopathy
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yurika |
| Middle name | |
| Last name | Terauchi |
Organization
The Jikei University School of Medicine
Division name
Department of Ophthalmology
Zip code
105-8471
Address
3-19-18, Nishishimbashi, Minato, Tokyo, 105-8471, Japan
TEL
03-3433-1111
yurika@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Yurika |
| Middle name | |
| Last name | Terauchi |
Organization
The Jikei University School of Medicine
Division name
Department of Ophthalmology
Zip code
105-8471
Address
3-19-18, Nishishimbashi, Minato, Tokyo, 105-8471, Japan
TEL
03-3433-1111
Homepage URL
yurika@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
The Jikei University School of Medicine
Address
3-19-18, Nishishimbashi, Minato, Tokyo, 105-8471, Japan
Tel
03-3433-1111
rinri@jikei.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.hindawi.com/journals/joph/2018/2837934/
Publication of results
Partially published
Result
URL related to results and publications
https://www.hindawi.com/journals/joph/2018/2837934/
Number of participants that the trial has enrolled
36
Results
The cut-off value for prediction of IFIS from the ROC curve was 7.20 mm for the pupil diameter, 58.7% for the PL ratio and 62.5% for the intuitive PL ratio.
The AUC for the ROC curve using the intuitive PL ratio (0.892) was high and no less than that for the ROC curve based on the pupil diameter (0.875) and PL ratio (0.913).
Results date posted
| 2020 | Year | 06 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male patients who were taking alpha1-ARAs at the time of cataract surgery
Participant flow
We retrospectively reviewed a consecutive series of eyes treated with cataract surgery at Jikei University Daisan Hospital from May 2014 to June 2016.
Adverse events
nothing
Outcome measures
0, no IFIS
1, mild IFIS
2, moderate IFIS
3, severe IFIS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All of Pupil diameter, PL ratio and intuitive PL ratio were negatively correlated with IFIS severity.
Management information
Registered date
| 2018 | Year | 06 | Month | 15 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037634
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
