UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003527 |
|---|---|
| Receipt number | R000004280 |
| Scientific Title | Research on macular pigment optical density and macular functional changes in pseudophakic eyes |
| Date of disclosure of the study information | 2010/05/06 |
| Last modified on | 2017/01/05 17:57:51 |
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Basic information
Public title
Research on macular pigment optical density and macular functional changes in pseudophakic eyes
Acronym
Macular pigment optical density in pseudophakic eyes
Scientific Title
Research on macular pigment optical density and macular functional changes in pseudophakic eyes
Scientific Title:Acronym
Macular pigment optical density in pseudophakic eyes
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate macular pigment optical density and macular functions in pseudophakic eyes
Basic objectives2
Others
Basic objectives -Others
To investigate the influence of intra ocular lens on the macular function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Macular pigment optical density
2)Electroretinography(ERG) of the macular area
Measurement: One-day, one month, three months, six months, and twelve months after the operation
Key secondary outcomes
1) Visual acuity
2) Intra ocular pressure
3) Contrast and glare sensitivity
4) Retinal morphology
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Yellow tinted intra ocular lens
HOYA PY-60AD
HOYA NY-60
Interventions/Control_2
Non-tinted intra ocular
HOYA PC-60AD
Alcon SA60AT
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
Patients who meet the following inclusion criteria:
1)With the prior written consent
2)Japanese
3)Patients to be qualified for this study based on the test results by the physician
Key exclusion criteria
1) Eyes with severe retinal diseases
2) Patients who request a specific intra ocular lens to be implanted
3) Eyes with difficulty of macular pigment measurement
4) Minority/person under age
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Obana |
Organization
Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name
Ophthalmology
Zip code
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka Pref. 430-8558
TEL
053-474-2222
webmaster@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ophthalmology |
Organization
Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name
Ophthalmology
Zip code
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka Pref. 430-8558
TEL
053-474-2222
Homepage URL
webmaster@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu Genaral Hospital (Shizuoka Prefecture)
Institute
Department
Personal name
Funding Source
Organization
HOYA Corporation Medical division
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shimane University (Shimane Prefecture)
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
聖隷浜松病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 06 | 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
| 2010 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 23 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004280
