UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029442 |
|---|---|
| Receipt number | R000033640 |
| Scientific Title | Comparison of anterior capsulotomy's postoperative long-term outcome by manual (anterior chamber forceps) and mechanical (Zepto) |
| Date of disclosure of the study information | 2017/10/05 |
| Last modified on | 2024/10/10 10:10:17 |
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Basic information
Public title
Comparison of anterior capsulotomy's postoperative long-term outcome by manual (anterior chamber forceps) and mechanical (Zepto)
Acronym
Comparison of anterior capsulotomy's postoperative long-term outcome by manual and Zepto
Scientific Title
Comparison of anterior capsulotomy's postoperative long-term outcome by manual (anterior chamber forceps) and mechanical (Zepto)
Scientific Title:Acronym
Comparison of anterior capsulotomy's postoperative long-term outcome by manual and Zepto
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of anterior capsulotomy's postoperative long-term outcome by manual and Zepto
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of anterior clouding and secondary cataract probability by manual using anterior chamber forceps and mechanical using Zepto.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
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
Mechanical surgery by using Zepto for anterior capsulotomy during cataract surgery
Interventions/Control_2
Manual surgery by using anterior chamber forceps for anterior capsulotomy during cataract surgery
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
20 years old or older.
Patient with declined eye sight due to cataract.
Patient wish to have cataract surgery on both eyes.
Diameter of the pupil must be 7.00mm or larger when dilated.
Anterior chamber depth must be 2.5mm or deeper.
Patient should comprehend and agree with the explanation from the doctor.
Key exclusion criteria
Congenital cataract
Patient with ocular disease other than cataract.
Patient with systemic disease such as diabetes or Marfan syndrome that may affect capsule.
Patient with eye disorder and systemic disease such as hypertension that does not affect capsule.
Pregnant or nursing woman.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-23 Sanbonmatsu, Atsuta-ku, Nagoya-shi, Aichi
TEL
052-683-5001
home@chukyomedical.co.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Ichikawa |
Organization
Japanese Red Cross Gifu Hospital
Division name
Department of Ophthalmology
Zip code
456-0032
Address
3-36 Iwakura-cho, Gifu-shi, Gifu
TEL
052-683-5001
Homepage URL
home@chukyomedical.co.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Chukyo Medical Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama Sky Eye Clinic
Manabe Eye Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chukyo Medical IRB
Address
12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya-city, Aichi
Tel
052-884-7976
irb@chukyomedical.co.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
| 2017 | Year | 10 | Month | 05 | 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
0
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033640
