UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031945 |
|---|---|
| Receipt number | R000036485 |
| Scientific Title | Preoperative estimation of distance between retinal break and limbus with wide-field fundus imaging: Possible clinical utility for scleral buckling |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/03/29 09:41:59 |
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Basic information
Public title
Preoperative estimation of distance between retinal break and limbus with wide-field fundus imaging: Possible clinical utility for scleral buckling
Acronym
Preoperative estimation of distance between retinal break and limbus with Optos
Scientific Title
Preoperative estimation of distance between retinal break and limbus with wide-field fundus imaging: Possible clinical utility for scleral buckling
Scientific Title:Acronym
Preoperative estimation of distance between retinal break and limbus with Optos
Region
| Japan |
Condition
Condition
Rhegmatogenous retinal detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Accurate scleral marking of retinal breaks is essential for successful scleral buckling. The aim of this study was to investigate if wide-field fundus images obtained with an Optos are useful for preoperative estimation of distance from limbus to retinal breaks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distances from limbus to anterior and posterior edge of scleral buckles
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
Cases who underwent scleral buckling surgery for rhegmatogenous retinal detachent between 1st Jan 2016 and 26th Sep 2017.
Key exclusion criteria
Cases who underwent previous surgery for rhegmatogenous retinal detachent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | KEIJIRO |
| Middle name | |
| Last name | ISHIKAWA |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Ophthalmology
Zip code
8128582
Address
3-1-1 Maidashi Higashi-ku, Fukuoka, JAPAN
TEL
0926425648
keijishi@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | KEIJIRO |
| Middle name | |
| Last name | ISHIKAWA |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Ophthalmology
Zip code
8128582
Address
3-1-1 Maidashi Higashi-ku, Fukuoka, JAPAN
TEL
0926425648
Homepage URL
keijishi@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI, Grant-in-Aid for Young Scientists (A)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KYUSHU UNIVERSITY Center for Clinical and Translational Research(CCTR)
Address
3-1-1 Maidashi Higashi-ku, Fukuoka, JAPAN
Tel
0926425774
bynintei@jimu.kyushu-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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212284
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212284
Number of participants that the trial has enrolled
29
Results
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212284
Results date posted
| 2020 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 02 | Month | 12 | Day |
Baseline Characteristics
Subjects
The subjects included patients whose fundus images that were taken with the method described in Image Acquisition allowed identification of retinal breaks, and who underwent explant scleral buckle surgery using silicone sponge primarily for rhegmatogenous retinal detachment, with anatomically successful repair between January 2016 and June 2017 at the Department of Ophthalmology, Kyushu University Hospital. Patients who required simultaneous cataract surgery and/or pars plana vitrectomy were excluded. The total number of eyes included for analysis was 29 eyes of 26 patients.
Participant flow
Subjects
The subjects included patients whose fundus images that were taken with the method described in Image Acquisition allowed identification of retinal breaks, and who underwent explant scleral buckle surgery using silicone sponge primarily for rhegmatogenous retinal detachment, with anatomically successful repair between January 2016 and June 2017 at the Department of Ophthalmology, Kyushu University Hospital. Patients who required simultaneous cataract surgery and/or pars plana vitrectomy were excluded. The total number of eyes included for analysis was 29 eyes of 26 patients.
Adverse events
None
Outcome measures
In the wide-field fundus images obtained with the software, we determined the center of the disc and the center of the vortex vein ampulla located in the same quadrant as the retinal tears as described previously. In the preoperative fundus images, we measured distances from the fovea to the center of retinal tears (TM), to the center of the vortex vein ampulla (VM), and to the center of the optic disc (DM1). In the postoperative fundus images, we measured distances from the fovea to the center of optic disc (DM2). The average distance from the fovea to the posterior edge of scleral buckle (BM) was calculated by averaging the distances measured from the fovea to three different buckle edges. A representative image taken from case number 19 (Table 1) illustrates these distance measurements in the wide-field fundus images obtained with the Optomap auto-montage software
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 03 | Month | 28 | Day |
Last modified on
| 2020 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036485
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