UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000438 |
|---|---|
| Receipt number | R000000532 |
| Scientific Title | Official scientific title of the study: Clinical evaluation of the patients after cataract surgery implanted intraocular lens with prolate anterior surface or spherical surface |
| Date of disclosure of the study information | 2006/06/30 |
| Last modified on | 2006/06/27 20:20:48 |
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Basic information
Public title
Official scientific title of the study: Clinical evaluation of the patients after cataract surgery implanted intraocular lens with prolate anterior surface or spherical surface
Acronym
Clinical evaluation of the patients after cataract surgery implanted intraocular lens with prolate anterior surface or spherical surface
Scientific Title
Official scientific title of the study: Clinical evaluation of the patients after cataract surgery implanted intraocular lens with prolate anterior surface or spherical surface
Scientific Title:Acronym
Clinical evaluation of the patients after cataract surgery implanted intraocular lens with prolate anterior surface or spherical surface
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate quality of vision after cataract surgery implanted prolate anterior surface intraocular lens and spherical surface intraocular lens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
preoperative and postoperative period; after one week, one month, and three month. visual acuity, contrast sensitivity, intraocular lens tilting, intraocular decentering, wave front analysis, pupil size
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
spherical surface intraocular lens(MA60BM) implanted eye
Interventions/Control_2
prolate anterior surface intra ocular lens(ZA9003)
Interventions/Control_3
normal volunteer without exclusion criteria
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 30 to 90 years with cataract visually impaired
2) Patients expected that the postoperative visual acuity were 0.8 or better.
Key exclusion criteria
1)Diabetic mellitus
2)Pseudoexforiation
3) operated laser iridotomy
4) ocular pathology other than cataract, cornea disease, uveitis, neurologic disease, glaucoma
5) elongated postoperative inflammation
6) drugs influenced on pupil size
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Aoki |
Organization
Jichi medical university
Division name
Department of pthalmology
Zip code
Address
3311-1 Yakushiji Shimotuke City Tochigi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jichi medical university
Division name
Department of ophthalmology
Zip code
Address
3311-1 Yakushiji Shimotuke City Tochigi
TEL
Homepage URL
Sponsor or person
Institute
Jichi medical university, department of ophthalmology
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2006 | Year | 06 | 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
Date of protocol fixation
| 2006 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 04 | 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
| 2006 | Year | 06 | Month | 27 | Day |
Last modified on
| 2006 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000532
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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