UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023790 |
|---|---|
| Receipt number | R000027408 |
| Scientific Title | Nd-YAG anterior capsulotomy for higher-order aberrations due to distortion of the acrylic IOL by capsular bag contraction after cataract surgery. |
| Date of disclosure of the study information | 2016/08/27 |
| Last modified on | 2020/09/18 13:56:01 |
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Basic information
Public title
Nd-YAG anterior capsulotomy for higher-order aberrations due to distortion of the acrylic IOL by capsular bag contraction after cataract surgery.
Acronym
Higher-order aberrations due to distortion of the acrylic IOL by capsular bag contraction.
Scientific Title
Nd-YAG anterior capsulotomy for higher-order aberrations due to distortion of the acrylic IOL by capsular bag contraction after cataract surgery.
Scientific Title:Acronym
Higher-order aberrations due to distortion of the acrylic IOL by capsular bag contraction.
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of diagnosis and treatment in postoperative higher-order aberrations that occur due to anterior capsular bag contraction and distortion of IOL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of higher-order aberrations were made using wavefront aberrometry (KR-1W-TOPCON) between pre- and post-operative Nd-YAG anterior capsulotomy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Nd-YAG anterior capsulotomy.once.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cases of postoperative higher-order aberrations occurred after cataract surgery.
Key exclusion criteria
cases not be mydriatic
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mitsutoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Ophthalmology Nakamura Clinic
Division name
Ophthalmology Nakamura Clinic
Zip code
8528061
Address
Opthalmology Nakamura Clinic,3-8-1 Nameshi, Nagasaki 852-8061 JAPAN
TEL
095-855-4300
mitsu777opt@gmail.com
Public contact
Name of contact person
| 1st name | Mitsutoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Ophthalmology Nakamura Clinic
Division name
Ophthalmology Nakamura Clinic
Zip code
8528061
Address
Opthalmology Nakamura Clinic,3-8-1 Nameshi, Nagasaki 85N2-8061 JAPA
TEL
095-855-4300
Homepage URL
mitsu777opt@gmail.com
Sponsor or person
Institute
Ophthalmology Nakamura Clinic
Institute
Department
Personal name
Funding Source
Organization
Ophthalmology Nakamura Clinic
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
nakamura eye clinic
Address
3-8-1 nameshi nagasaki
Tel
0958554300
mitsu777opt@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
| 2016 | Year | 08 | Month | 27 | 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
8
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 18 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 18 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 27 | Day |
Last modified on
| 2020 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027408
