UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000031945
Receipt No. 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 (Ver. 6)

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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
Email 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
Email keijishi@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu university hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036485