UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028951 |
|---|---|
| Receipt number | R000033127 |
| Scientific Title | Prospective field study on crystalline lens reconstructive operation using multifocal intraocular lens |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2019/03/04 09:05:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective field study on crystalline lens reconstructive operation using multifocal intraocular lens
Acronym
Prospective field study on crystalline lens reconstructive operation using multifocal intraocular lens
Scientific Title
Prospective field study on crystalline lens reconstructive operation using multifocal intraocular lens
Scientific Title:Acronym
Prospective field study on crystalline lens reconstructive operation using multifocal intraocular lens
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research the surgical outcome ad patient satisfaction of multifocal intraocular lens within Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Uncorrected visual acuity (far, near), corrected visual acuity (far, near)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient willing to have crystalline lens reconstructive operation using multifocal intraocular lens at a facility registered in Japanese Society of Cataract and Refractive Surgery's advanced medical care registration (crystalline lens reconstructive operation using multifocal intraocular lens)
Key exclusion criteria
Patient who did not agree with this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Vision Research Laboratory
Zip code
Address
12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi
TEL
052-883-1543
ichikawa@chukyogroup.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Sakai |
Organization
Chukyo Eye Clinic
Division name
Orthoptist
Zip code
Address
12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi
TEL
052-883-1543
Homepage URL
sakai@chukyo-eyeclinic.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yuya Sato Eye Clinic
Tomita Eye Clinic
Hoshino Eye Clinic
Sugata Eye Clinic
Iida Municipal Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 09 | Month | 01 | 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
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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | 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
none
Management information
Registered date
| 2017 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033127
