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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030788
Receipt No. 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

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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
Email 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
Email hayashi-ken@hayashi.or.jp

Sponsor
Institute Hayashi Eye Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035155

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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