UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014686
Receipt No. R000017074
Scientific Title A randomized controlled study about the influence of cataract surgery with spherical intra ocular lens (IOL) and aspherical IOL on pseudoaccommodation and visual function among elderly people
Date of disclosure of the study information 2014/07/28
Last modified on 2014/07/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A randomized controlled study about the influence of cataract surgery with spherical intra ocular lens (IOL) and aspherical IOL on pseudoaccommodation and visual function among elderly people
Acronym A randomized controlled study about the influence of spherical intra ocular lens (IOL) and aspherical IOL with cataract surgery on pseudoaccmmodation and visual function among elderly people
Scientific Title A randomized controlled study about the influence of cataract surgery with spherical intra ocular lens (IOL) and aspherical IOL on pseudoaccommodation and visual function among elderly people
Scientific Title:Acronym A randomized controlled study about the influence of spherical intra ocular lens (IOL) and aspherical IOL with cataract surgery on pseudoaccmmodation and visual function among elderly people
Region
Japan

Condition
Condition cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compare the pseudoaccommodation and subjective visual function between spherical IOL group and aspherical IOL group after cataract surgery.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Pseudoaccommodation
Japanese version of the National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
Key secondary outcomes Aberration(Spherical, Coma)
Contrast sensitivity
Ophthalmological examinations(visual acuity,intraocular pressure, axial length,cornea endothelial cell,pupil diameter)
Retinal and Choroidal thickness
Retinal disease
Visual field
Subjective sleep(PSQI: Pittsburgh Sleep Quality Index)
Depressive symptoms(GDS: Geriatic Depression Scale)
Physical activity(Actigraph)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Spherical IOL group
Phacoemulsification and spherical IOL implantation(SN60AT(Alcon)).
Interventions/Control_2 Aspherical IOL group
Phacoemulsification and aspherical IOL implantation (SN60WF(Alcon)).
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)patients scheduled for the first cataract
surgery
2)age <=60 years
3)cataract with <=grade 2 nuclear
opacification according to LOCS III
Key exclusion criteria 1)severe mental illness and dementia
2)severe corneal opacity
3)glaucoma with visual field deficit of at least
MD>14dB (Humphrey Perimeter)
4)vitreous haemorrhage
5)proliferative diabetic retinopathy
6)macular edema
7)age-related macular degeneration
8)patients needing emergent cataract surgery
9)patients needing combined cataract and
glaucoma surgery or combined cataract
surgery and vitrectomy
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nahoko Ogata
Organization Nara Medical University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL 0744-29-8884
Email ogata@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomo Nishi
Organization Nara Medical University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL 0744-29-8884
Homepage URL
Email tomon@naramed-u.ac.jp

Sponsor
Institute Department of Ophthalmology
Nara Medical University School of Medicine
Institute
Department

Funding Source
Organization Nara Medical University School of Medicine
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 奈良県立医科大学付属病院
Nara Medical University Hospital

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 28 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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 28 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
2014 Year 07 Month 28 Day
Last modified on
2014 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017074

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.