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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000438
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Jichi medical university, department of ophthalmology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000532

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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