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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036588
Receipt No. R000041612
Scientific Title Clinical trial of YAG laser vitreolysis for Weiss ring after posterior vitreous detachment
Date of disclosure of the study information 2019/04/24
Last modified on 2019/04/24

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Basic information
Public title Clinical trial of YAG laser vitreolysis for floater caused by Weiss ring
Acronym Clinical trial of YAG laser vitreolysis for floater caused by Weiss ring
Scientific Title Clinical trial of YAG laser vitreolysis for Weiss ring after posterior vitreous detachment
Scientific Title:Acronym Clinical trial of YAG laser vitreolysis for Weiss ring after posterior vitreous detachment
Region
Japan

Condition
Condition floater caused by Weiss ring
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A multi-center randomized, single-blind, controlled trial to evaluate safety and efficacy of the YAG laser vitreolysis for Weiss ring after posterior vitreous detachment.by comparing treated group with the sham YAG laser (placebo) treated group.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Subjective change measured by visual questionnaire
Key secondary outcomes a) visual acuity
b) ultrasound B scan
c) optical coherence tomography; OCT
d) fundus photo image
e) slit lamp examination, indirect ophthalmoscope,intra ocular pressure
f) National Eye Institute Visual Functioning Questionnaire 25(VFQ-25)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 YAG laservitreolysis
Interventions/Control_2 sham YAG laser
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) at least 6 month of symptom associated with floaters
2) posterior vitreous detachment confirmed by clinical examination, OCT and ultrasound B scan
3) more than 4 on the score of visual disturbance due to floaters (0 = no symptom, 10 = intolerable)
4) Weiss ring more than 3 mm away from the retina and 5 mm away from the lens not applicable if pseudophakic patients) by B scan
5) able to take position for YAG laser
6) understands the risk of YAG laser resulting in retinal detachment, intraocular hemorrhage, retinal injury, cataract formation, optic disc injury, inflammation, and other events causing visual disturbance
7) willing to cooperate to the study protocol
8) only one eye for the study even if the patient had symptom in both eye
9) willing to sign informed consent
Key exclusion criteria 1) fellow eye with best corrected visual acuity bellow 0.4(20/50)
2) history of retinal break, retinal detachment, uveitis in the study eye
3) history of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye
4) ongoing treatment of glaucoma or ocular hypertension by more than 2 kinds of glaucoma topical medication, history of glaucoma surgery in the study eye
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Shigeru
Middle name
Last name Kinoshita
Organization ShijoKarasuma-Ganka Komuro Clinic
Division name Department of Ophthalmology
Zip code 604-8152
Address 4th Floor High-medic Court, 652 Tearaimizu-cho, Nakagyo-ku, Kyoto
TEL 075-708-8004
Email shigeruk@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Misawa
Organization The Study Group for Laser Vitreolysis
Division name Secretariat
Zip code 104-0053
Address 3rd floor Harumi Park Building, 3-2-22 Harumi, Chuo-ku, Tokyo
TEL 090-6009-7912
Homepage URL https://laser-vitreolysis.net
Email study1@laser-vitreolysis.net

Sponsor
Institute The Study Group for Laser Vitreolysis
Institute
Department

Funding Source
Organization The Study Group for Laser Vitreolysis
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 Review Board
Address 5th Floor, 15th Hase Building, 688 Takanna-cho, Nakagyo-ku, Kyoto
Tel 075-746-6835
Email Keigo.ishikawa1027@gmail.com

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
2019 Year 04 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 49
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 11 Month 28 Day
Date of IRB
2017 Year 01 Month 04 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 24 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041612

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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