UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033661 |
|---|---|
| Receipt number | R000038376 |
| Scientific Title | Efficacy study of cataract surgery using femtosecond laser |
| Date of disclosure of the study information | 2018/08/07 |
| Last modified on | 2021/02/08 17:09:18 |
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Basic information
Public title
Efficacy study of cataract surgery using femtosecond laser
Acronym
Study of FLACS efficacy
Scientific Title
Efficacy study of cataract surgery using femtosecond laser
Scientific Title:Acronym
Study of FLACS efficacy
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare postoperative progress of FLACS by multiple surgeons
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complications, visual acuity and intraocular pressue one day, 5 days, 1 month, 3 months, 6 months after the surgery, corneal endothelial cell density, flare value, corneal shape will be studied and slit lamp microscopy will be conducted.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Femtosecond laser cataract surgery device will be used during cataract surgery (operator A)
Interventions/Control_2
Femtosecond laser cataract surgery device will be used during cataract surgery (operator B)
Interventions/Control_3
Femtosecond laser cataract surgery device will be used during cataract surgery (operator C)
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with visual function disorder due to cataract
Emery-Little classification of grade I to IV cataract
Key exclusion criteria
Patient with Grade V cataract of Emery-Little classification, mature cataract, hypermature cataract, corneal disease, corneal opacity, macular disease or advanced glaucoma patient who is likely to have lower visual acuity after the surgery, uncontrolled diabetes, patient who cannot fix vision intraoperatively, who cannot rest, open eyelid, dilate pupil (exfoliation syndrome, etc.) , and patient with history of trauma.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Ophthalmology
Zip code
4560032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL
052-883-1543
ichikawa@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Mitamura |
Organization
Chukyo Eye Clinic
Division name
Ophthalmology
Zip code
4560032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL
052-883-1543
Homepage URL
takagi@chukyogroup.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
none
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
IRB of Chukyo Medical Co.,Ltd
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
| 2018 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
| 2018 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2021 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038376
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
