UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021114 |
|---|---|
| Receipt number | R000024362 |
| Scientific Title | Intraviteal injection of povidone iodine resulting in 0.025% vitreal concentration for initial treatment of endophthalmitis |
| Date of disclosure of the study information | 2016/02/20 |
| Last modified on | 2018/10/05 12:40:59 |
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Basic information
Public title
Intraviteal injection of povidone iodine resulting in 0.025% vitreal concentration for initial treatment of endophthalmitis
Acronym
Initial treatment of endophthalmitis using 0.025% vitreal concentration PI
Scientific Title
Intraviteal injection of povidone iodine resulting in 0.025% vitreal concentration for initial treatment of endophthalmitis
Scientific Title:Acronym
Initial treatment of endophthalmitis using 0.025% vitreal concentration PI
Region
| Japan |
Condition
Condition
endophthalmitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the safety of intravitreal injection of 1.25% povidone iodine/0.1ml for the treatment of endophthalmitis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative complications due to intravitreal povidone iodine after 3-months
Key secondary outcomes
The result of bacterial culture before intravitreal injection and after vitrectomy, 3-months postoperative visual acuity, recurrence of endophthalmitis within 3 months, operative complicatios
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
povidone iodine(1.25mg/0.1ml)
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cases of endophthalmitis
Key exclusion criteria
none
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nakashizuka |
Organization
Nihon University hospital
Division name
Ophthalmology
Zip code
Address
1-6surugadai kanda chiyoda-ku
TEL
03-3293-1711
nakashizuka.hiroyuki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nakashizuka |
Organization
Nihon University hospital
Division name
Ophthalmology
Zip code
Address
1-6surugadai kanda chiyoda-ku
TEL
03-3293-1711
Homepage URL
nakashizuka.hiroyuki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University hospital
Organization
Division
Category of Funding Organization
Other
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
日本大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 20 | 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
Nine eyes of 8 patients with postoperative or endogenous endophthalmitis were included and studied at the Nihon University Hospital between April 2015 and October 2017.Results: In all but case 7, endophthalmitis resolved rapidly and maintained good visual acuity. No adverse event was noted. Furtheremore, the perioperative ERG showed the improvement in the amplitude of the OPs and flicker ERG and in the implicit time of the a-wave, suggesting functional recovery in retinal outer and inner layers after the therapy.
Conclusion: IVI of PI followed by vitrectomy was thought to be safe and effective as a treatment for endophthalmitis.
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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 29 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 20 | Day |
Last modified on
| 2018 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024362
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/10/05 | PI硝子体注射＋灌流液（中静-赤文字）.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
