UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014686 |
|---|---|
| Receipt number | 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 | 2024/04/26 17:10:45 |
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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 | Tomo |
| Middle name | |
| Last name | Nishi |
Organization
Nara Medical University School of Medicine
Division name
Department of Ophthalmology
Zip code
6348522
Address
840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL
0744-29-8884
ogata@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomo |
| Middle name | |
| Last name | Nishi |
Organization
Nara Medical University School of Medicine
Division name
Department of Ophthalmology
Zip code
6348522
Address
840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL
0744-29-8884
Homepage URL
tomon@naramed-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology
Nara Medical University School of Medicine
Institute
Department
Personal name
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
Nara Medical University Certified Review Board
Address
840 Shijo cho Kashihara, Nara
Tel
0744-22-3051
ychiken@naramed-u.ac.jp
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
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017074
