UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053376 |
|---|---|
| Receipt number | R000060922 |
| Scientific Title | Nation-wide investigation of severe complications after strabismus surgery in Japan |
| Date of disclosure of the study information | 2025/04/02 |
| Last modified on | 2026/09/04 09:51:05 |
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Basic information
Public title
Nation-wide investigation of severe complications after strabismus surgery in Japan
Acronym
Severe complications after strabismus surgery in Japan
Scientific Title
Nation-wide investigation of severe complications after strabismus surgery in Japan
Scientific Title:Acronym
Severe complications after strabismus surgery in Japan
Region
| Japan |
Condition
Condition
Strabismus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate severe complication rate after strabismus surgery in Japan
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of severe complication after strabismus surgery
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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 and Female
Key inclusion criteria
Present or previous surgeons at an institution where many strabismus surgeries are performed
Key exclusion criteria
Nothing
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Miyata |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3248
miyatam@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Miyata |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3248
Homepage URL
miyatam@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Strabismus and Amblyopia
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4642
ethcom@kuhp.kyoto-u.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
| 2025 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000060922
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/42358618/
Number of participants that the trial has enrolled
97
Results
The incidence rates of severe complications per 100,000 surgeries were 0.92 for infectious endophthalmitis, 1.84 for orbital cellulitis, 8.29 for anterior segment ischemia (grade 3 or higher), and 3.68 for scleral perforation with retinal detachment. For perioperative management, 91.8% of the surgeons used povidone-iodine immediately before surgery, 100% prescribed postoperative antibiotics, 74.2% used adhesive drapes, and 87.6% conducted the first postoperative follow-up examination on day 1.
Results date posted
| 2026 | Year | 09 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ninety-seven active strabismus specialists affiliated with the Japanese Association for Strabismus and Amblyopia. The total number of analyzed strabismus surgeries was 108,623.
Participant flow
We sent the questionnaire to 210 strabismus specialists and received 99 responses (response rate, 47.1%). After excluding 2 nonsurgical respondents, we analyzed data from 97 active surgeons.
Adverse events
No
Outcome measures
The number of severe complications, including infectious endophthalmitis, orbital cellulitis, anterior segment ischemia (grade 3 or higher), and scleral perforation with retinal detachment, as well as perioperative management protocols.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire for strabismus surgeons
Management information
Registered date
| 2024 | Year | 01 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060922
