UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027323 |
|---|---|
| Receipt number | R000031310 |
| Scientific Title | Postoperative outcomes of diffractive multifocal intraocular lens for juvenile cataract eye |
| Date of disclosure of the study information | 2017/09/30 |
| Last modified on | 2017/05/12 16:55:58 |
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Basic information
Public title
Postoperative outcomes of diffractive multifocal intraocular lens for juvenile cataract eye
Acronym
Diffractive multifocal intraocular lens for juvenile cataract eye
Scientific Title
Postoperative outcomes of diffractive multifocal intraocular lens for juvenile cataract eye
Scientific Title:Acronym
Diffractive multifocal intraocular lens for juvenile cataract eye
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the postoperative results of multifocal diffractive IOL among young patients retrospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient background (past history, corneal astigmatism, ocular axial length, lens opacity), uncorrected/uncorrected distance/near logMAR visual acuity at the 3 months after surgery,
Key secondary outcomes
contrast sensitivity, frequency of spectacle wearing, and additional refractive surgery were examined from clinical records
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
| 19 | years-old | < |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Young age ranging from19 to 39 years old (average 31.8 years old) who inserted +4.00 addition diffractive multifocal IOL (ZMA00, ZMB00: Abbott) at Tokyo Dental College Suidobashi Hospital from 2009 to 2013 during Cataract surgery.
Key exclusion criteria
Lens subluxation, irregular corneal astigmatism, corneal opacity, history of retinal detachment, glaucoma, uveitis, and diseases affectiong visual function.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Bissen-Miyajima |
Organization
Tokyo Dental College Suidobashi Hospital
Division name
Department of Ophthalmology
Zip code
Address
Misakicho 2-9-18, Chiyoda-ku, Tokyo 101-0061
TEL
03-5275-1856
bissen@tdc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Bissen-Miyajima |
Organization
Tokyo Dental College Suidobashi Hospital
Division name
Department of Ophthalmology
Zip code
Address
Misakicho 2-9-18, Chiyoda-ku, Tokyo 101-0061
TEL
03-5275-1856
Homepage URL
hirasawa@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental College Suidobashi Hospital
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
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 | 30 | 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
| 2016 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
n.c.
Management information
Registered date
| 2017 | Year | 05 | Month | 12 | Day |
Last modified on
| 2017 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031310
