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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023790
Receipt No. 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 2017/02/27

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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
Middle name
Last name Mitsutoshi Nakamura
Organization Ophthalmology Nakamura Clinic
Division name Ophthalmology Nakamura Clinic
Zip code
Address Opthalmology Nakamura Clinic,3-8-1 Nameshi, Nagasaki 852-8061 JAPAN
TEL 095-855-4300
Email mitsu777opt@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mitsutoshi Nakamura
Organization Ophthalmology Nakamura Clinic
Division name Ophthalmology Nakamura Clinic
Zip code
Address Opthalmology Nakamura Clinic,3-8-1 Nameshi, Nagasaki 85N2-8061 JAPA
TEL 095-855-4300
Homepage URL
Email mitsu777opt@gmail.com

Sponsor
Institute Ophthalmology Nakamura Clinic
Institute
Department

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
Address
Tel
Email

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
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
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 27 Day
Last modified on
2017 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027408

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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