UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046872 |
|---|---|
| Receipt number | R000053471 |
| Scientific Title | Real-world Long-term Treatment Result in Retinopathy of Prematurity: A Multicenter Cohort Study |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2024/08/12 22:42:07 |
* 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
Real-world Long-term Treatment Result in Retinopathy of Prematurity: A Multicenter Cohort Study
Acronym
Treatment Result in ROP: A Multicenter Cohort Study
Scientific Title
Real-world Long-term Treatment Result in Retinopathy of Prematurity: A Multicenter Cohort Study
Scientific Title:Acronym
Treatment Result in ROP: A Multicenter Cohort Study
Region
| Japan |
Condition
Condition
Retinopathy of Prematurity
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the real-world, long-term outcomes of children treated for retinopathy of prematurity (ROP)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity and ocular complications at five years of ages
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 and Female
Key inclusion criteria
Births between January 2001 and June 2016
History of treatment for ROP
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Murakami |
Organization
University of Tsukuba
Division name
Department of Ophthalmology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-3148
tomoyam618@gmail.com
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Murakami |
Organization
University of Tsukuba
Division name
Department of Ophthalmology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-3148
Homepage URL
tomoyam618@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board of the Tsukuba University Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
| 2022 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41433-023-02559-z
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41433-023-02559-z
Number of participants that the trial has enrolled
139
Results
The initial treatment procedure (laser vs anti-VEGF) was not associated with any specific treatment outcome (best corrected visual acuity(BCVA), spherical equivalent(SE), presence of amblyopia and strabismus). Subgroup analysis of patients with zone I ROP revealed that the anti-VEGF-treated eyes had significantly better BCVA and higher SE than laser-treated eyes. Female patients presented significantly better BCVA, less amblyopia and less strabismus than male patients.
Results date posted
| 2024 | Year | 08 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 139 cases of Type 1 ROP that received treatment. The initial treatment was laser therapy (laser group) in 99 cases and anti-VEGF therapy (anti-VEGF group) in 40 cases. Among them, 45 were male in the laser group and 25 in the anti-VEGF group (p = 0.092). The gestational age at birth was 26.4 +- 2.1 weeks and 26.0 +- 2.3 weeks (p = 0.287), the birth weight was 821 +- 257g and 731 +- 257g (p = 0.065), the Apgar score at 1 minute was 4.6 +- 2.6 and 3.7 +- 2.4 (p = 0.069), and at 5 minutes was 7.4 +- 2.0 and 5.5 +- 2.8 (p < 0.001), respectively.
Participant flow
N/A (due to the retrospective nature of the study)
Adverse events
None
Outcome measures
Best corrected visual acuity, spherical equivalent, presence of amblyopia and strabismus
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
a multi-center retrospective observational study
Management information
Registered date
| 2022 | Year | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053471
