UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030788 |
|---|---|
| Receipt number | R000035155 |
| Scientific Title | Short-term Dynamics after Single- and Three-piece Acrylic Intraocular Lens Implantation: A Swept-source Anterior Segment Optical Coherence Tomography Study |
| Date of disclosure of the study information | 2018/01/12 |
| Last modified on | 2018/01/12 18:04:07 |
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Basic information
Public title
Short-term Dynamics after Single- and Three-piece Acrylic Intraocular Lens Implantation: A Swept-source Anterior Segment Optical Coherence Tomography Study
Acronym
Short-term Dynamics after Single- and Three-piece Intraocular Lens Implantation
Scientific Title
Short-term Dynamics after Single- and Three-piece Acrylic Intraocular Lens Implantation: A Swept-source Anterior Segment Optical Coherence Tomography Study
Scientific Title:Acronym
Short-term Dynamics after Single- and Three-piece Intraocular Lens Implantation
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate short-term dynamics after single- and three-piece intraocular lens (IOL) implantation procedures, utilizing identical IOL material from a single manufacturer, after uneventful phacoemulsification by swept-source anterior segment optical coherence tomography
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurements of intraocular lens decentration and tilt, and measurements of anterior chamber depth were performed at 3 hours, 24 hours, 2 weeks, and 4 weeks after surgery, using the anterior segment optical coherence tomography.
Key secondary outcomes
Measurements of spherical equivalent and uncorrected distance visual acuity before surgery, as well as at 24 hours, 2 weeks, and 4 weeks after surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Fifty patients who were scheduled for bilateral cataract surgery were randomly assigned to one of two groups.
Interventions/Control_2
These25 patients who were to receive a single-piece intraocular lens (IOL) in the right eye and a three-piece IOL in the left eye; and 25 patients who were to receive the three-piece IOL in the right eye and the single-piece IOL in the left eye.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A hundred eyes of consecutive 50 patients who were scheduled for bilateral cataract surgery between March 2016 and April 2017.
Key exclusion criteria
Ocular pathology other than cataract that might affect visual acuity; history of ocular surgery and/or inflammation; eyes scheduled for extracapsular or intracapsular cataract extraction; less than 6.0 mm pupil diameter after mydriasis; pseudoexfoliation syndrome; diabetes; and patients not available for follow-up.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Hayashi |
Organization
Hayashi Eye Hospital
Division name
Department of Ophthalmology
Zip code
Address
4-23-35, Hakataekimae, Hakata-ku,Fukuoka, Japan
TEL
092-431-1680
hayashi-ken@hayashi.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Hayashi |
Organization
Hayashi Eye Hospital
Division name
Department of Ophthalmology
Zip code
Address
4-23-35, Hakataekimae, Hakata-ku,Fukuoka, Japan
TEL
092-431-1680
Homepage URL
hayashi-ken@hayashi.or.jp
Sponsor or person
Institute
Hayashi Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
林眼科病院（福岡県） Hayashi Eye Hospital (Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 12 | 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
| 2016 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 20 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 12 | Day |
Last modified on
| 2018 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035155
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| Registered date | File name |
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| Registered date | File name |
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