UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044376 |
|---|---|
| Receipt number | R000050690 |
| Scientific Title | Antibiotic prophylaxis of endophthalmitis after cataract surgery: network meta-analysis |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2022/11/18 16:59:47 |
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Basic information
Public title
Antibiotic prophylaxis of endophthalmitis after cataract surgery: network meta-analysis
Acronym
Antibiotic prophylaxis of endophthalmitis after cataract surgery: network meta-analysis
Scientific Title
Antibiotic prophylaxis of endophthalmitis after cataract surgery: network meta-analysis
Scientific Title:Acronym
Antibiotic prophylaxis of endophthalmitis after cataract surgery: network meta-analysis
Region
| Japan |
Condition
Condition
endophthalmitis after cataract surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cataract surgery is the most commonly performed procedure in many industrialized countries, and its frequency continues to increase. Reasons for this include changes in the demographic composition of the population, improved technologies.
Endophthalmitis is an inflammation of the lumen of the eye, usually caused by an infection. It is a possible complication of all intraocular surgeries, especially cataract surgery, and can lead to loss of vision. The most common cause of postoperative endophthalmitis is bacteria directly inoculated by the surgery. Therefore, perioperative antibiotic is a reasonable strategy to reduce the risk of postoperative endophthalmitis. In daily practice, a variety of antibiotics has been used to prevent post-operative endophthalmitis and they can be administrated as irrigation during the operation, intracameral injection, or topical administration. However, benefit of antibiotic use had not been sufficiently clear until recently mainly because incidence of post cataract surgery endophthalmitis is less than 0.1%. Thus, pooled analysis was warranted for this topic. Published meta-analyses revealed that perioperative intracameral vancomycin/moxifloxacin, anterior chamber injection of moxifloxacin after cataract surgery, and intracameral cefuroxime and moxifloxacin after cataract surgery reduce the risk of endophthalmitis compared to no antibiotic prophylaxis. However, the best antibiotic type and the best administration route for cataract surgery are still not known. The current systematic review is to reveal the preferred antibiotics using data from both randomized controlled trials and observational studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
endophthalmitis after cataract 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
Both randomized controlled trials and observational studies will be included as long as they were written in English language and provided sufficient data. Conference abstract are permitted.
Eyes with cataracts after surgery will be analyzed.
Key exclusion criteria
NA
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Chemotherapy Center
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
+810081457872800
horitano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Chemotherapy Center
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
+810081457872800
Homepage URL
horitano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
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
Yokohama C
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
+810081457872800
horitano@yokohama-cu.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
| 2021 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36258003/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36258003/
Number of participants that the trial has enrolled
6809732
Results
Intracameral injection of vancomycin had the best preventive effect (odds ratio [OR] 0.03, 99.6% confidence interval [CI] 0.00-0.53, corrected P-value = 0.006, P-score = 0.945) followed by intracameral injection of cefazoline (OR 0.09, 99.6% CI 0.02-0.42, corrected P-value < 0.001, P-score = 0.821), cefuroxime (OR 0.18, 99.6% CI 0.09-0.35, corrected P-value < 0.001, P-score = 0.660), and moxifloxacin (OR 0.36, 99.6% CI 0.16-0.79, corrected P-value = 0.003, P-score = 0.455).
Results date posted
| 2022 | Year | 11 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See:
Ai Kato et al. Sci Rep. 2022 Oct 18;12(1):17416. doi: 10.1038/s41598-022-21423-w.
Participant flow
See:
Ai Kato et al. Sci Rep. 2022 Oct 18;12(1):17416. doi: 10.1038/s41598-022-21423-w.
Adverse events
See:
Ai Kato et al. Sci Rep. 2022 Oct 18;12(1):17416. doi: 10.1038/s41598-022-21423-w.
Outcome measures
See:
Ai Kato et al. Sci Rep. 2022 Oct 18;12(1):17416. doi: 10.1038/s41598-022-21423-w.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Any antibiotics via any route will be accepted. Combined regimen with two or more antibiotics were also allowed.
Newcastle-Ottawa quality assessment scale for cohort studies will be used for quality assessment.
Treatment arm should be determined by both antibiotics type and administration route for the main analysis. Sensitivity analyses focusing on only antibiotic type and only administration route are planned.
Proportion of eyes with endophthalmitis will be compared between the two treatment groups using odds ratios (ORs). If one or more cells are null in a two-by-two contingency table, 0.5 will be added to all cells as continuity correction. The logarithm of the ORs and their standard errors will be pooled by the "netmeta" package in R. The logarithm of ORs and their standard errors will be pooled by frequentist weighted least squares approach random-model network meta-analysis.
Management information
Registered date
| 2021 | Year | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050690
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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