UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036588 |
|---|---|
| Receipt number | 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 | 2020/05/05 18:22:19 |
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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
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
study1@laser-vitreolysis.net
Sponsor or person
Institute
The Study Group for Laser Vitreolysis
Institute
Department
Personal name
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
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
https://laser-vitreolysis.net
Publication of results
Unpublished
Result
URL related to results and publications
https://laser-vitreolysis.net
Number of participants that the trial has enrolled
49
Results
In the YAG laser vitreolysis group, the 10-point visual disturbance score improved by 2.5 vs 0.4 in the sham group (difference, -2.1; 95% CI, -3.3 to -0.9; P < .001). The YAG laser vitreolysis group reported greater symptomatic improvement (54%) than controls (18%) (difference, 36.1; 95% CI, 20.0-52.3; P < .001).
Results date posted
| 2020 | Year | 05 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean (SD) age of participants was 60.2 (10.0) years in the YAG laser vitreolysis treatment group (age range, 41-79 years; median age 60 years) and 60.5 (11.2) years in the sham group (age range, 40-88 years; median age, 60 years).
Participant flow
49 patients (49 eyes; 18 men and 31 women) with symptomatic Weiss rings were enrolled and followed for 6 months.
Adverse events
In the YAG laser vitreolysis group, no adverse events, including lens or retinal injury, were observed. In the sham group, one participant had pneumonia during the study period and admitted to the hospital.
Outcome measures
Primary outcome at 6 months were subjective changes measured using a 10-point visual disturbance score. Secondary outcomes included improvement of visual disturbance expressed by percentage and a 5-level qualitative scale compared to baseline, postoperative floater symptoms (subjective symptoms and objective symptoms evaluated by funduscopy), and National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25).
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
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 24 | Day |
Last modified on
| 2020 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041612
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