UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012461 |
|---|---|
| Receipt number | R000014584 |
| Scientific Title | Analysis of ocular higher-order aberrations and visual functions one month after implantation of four aspheric IOLs |
| Date of disclosure of the study information | 2013/12/04 |
| Last modified on | 2013/12/02 16:43:09 |
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Basic information
Public title
Analysis of ocular higher-order aberrations and visual functions one month after implantation of four aspheric IOLs
Acronym
Analysis of ocular higher-order aberrations and visual functions one month after implantation of four aspheric IOLs
Scientific Title
Analysis of ocular higher-order aberrations and visual functions one month after implantation of four aspheric IOLs
Scientific Title:Acronym
Analysis of ocular higher-order aberrations and visual functions one month after implantation of four aspheric IOLs
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the ocular higher-order aberrations and visual functions of the implanted four aspheric IOLs one month after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal,internal and ocular higher order aberrations, best corrected visual acuity and contrast sensitivity one month after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
W-60,Santen
Interventions/Control_2
SN60WF,Alcon
Interventions/Control_3
ZCB00,AMO
Interventions/Control_4
NY-60,HOYA
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who understand the contents of this study, and provided a written informed consent
Patients who are scheduled for cataract surgery.
Key exclusion criteria
Patients with other ocular pathologies,
intraoperative or postoperative complications, high hyperopia(+6.0 diopters [D] or greater), high myopia(-
6.0 D or greater) and history of other ocular surgery.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naofumi Kita |
Organization
Egychi Eye Hospital
Division name
medical office
Zip code
Address
Suehiro town 7-13,Hakodate city,Hokkaidou,Japan
TEL
0138232272
kita@eguchiganka.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nasofumi Kita |
Organization
Egychi Eye Hospital
Division name
medical office
Zip code
Address
Suehiro town 7-13,Hakodate city,Hokkaidou,Japan
TEL
0138232272
Homepage URL
kita@eguchiganka.co.jp
Sponsor or person
Institute
Egychi Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
Egychi Eye Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 12 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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
| 2013 | Year | 12 | Month | 02 | Day |
Last modified on
| 2013 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014584
