UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033629 |
|---|---|
| Receipt number | R000038332 |
| Scientific Title | Comparison of intraocular lens location after Phacovitrectomy and Cataract surgery |
| Date of disclosure of the study information | 2018/08/06 |
| Last modified on | 2020/08/04 13:06:59 |
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Basic information
Public title
Comparison of intraocular lens location after Phacovitrectomy and Cataract surgery
Acronym
IOL location after phacovitrectomy
Scientific Title
Comparison of intraocular lens location after Phacovitrectomy and Cataract surgery
Scientific Title:Acronym
IOL location after phacovitrectomy
Region
| Japan |
Condition
Condition
Posterior segment diseases, Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate dynamics of 2 kinds of single-piece intraocular lens after uneventful phacovitrectomy 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 at 1 week, 1 months, and 3 months after surgery, using an anterior segment optical coherence tomography.
Key secondary outcomes
Measurements of spherical equivalent and uncorrected/corrected distance visual acuity before surger, as well as 1 week, 1 month, and 3 months 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
Sixty patients who are scheduled for phacovitrectomy are randomly assigned to one of two groups.
Interventions/Control_2
One of 2 kinds of single-piece intraocular lenses are implanted to each group. Sixty patients who are scheduled for cataract surgery are enrolled as control.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Sixty eyes of consecutive 60 patients who are scheduled for phacovitrectomy. Sixty eyes of consecutive 60 patients who are scheduled for cataract surgery.
Key exclusion criteria
Patients in which an intraocular lenses cannot be implanted in the capsular bag. Patients with weak Zinn's zonule. Patients scheduled for receiving long-acting gas or silicone oil in the vitreous cavity. Patients scheduled for extracapsular or intracapsular cataract extraction. Less than 6.0 mm pupil diameter after mydriasis. Patients not available for follow-up.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Sato |
Organization
Hayashi Eye Hospital
Division name
Department of Ophthalmology
Zip code
8120011
Address
4-23-35, Hakataekimae, Hakata-ku,Fukuoka-city,Fukuoka
TEL
092-431-1680
tatsusatou@hayashi.or.jp
Public contact
Name of contact person
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Sato |
Organization
Hayashi Eye Hospital
Division name
Department of Ophthalmology
Zip code
8120011
Address
4-23-35, Hakataekimae, Hakata-ku,Fukuoka-city,Fukuoka
TEL
092-431-1680
Homepage URL
tatsusatou@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
Institutional Review Board of Hayashi Eye Hospital
Address
4-23-35, Hakataekimae, Hakata-ku,Fukuoka, Japan
Tel
092-431-1680
mihara-seiya@hayashi.or.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
林眼科病院（福岡県）Hayashi Eye Hospital (Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S2468653020300427?via%3Dihub
Publication of results
Unpublished
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S2468653020300427?via%3Dihub
Number of participants that the trial has enrolled
120
Results
Neither myopic shift nor IOL displacement occurs after 25-gauge phacovitrectomy with a single-piece IOL without gas injection for macular pathology compared with phacoemulsification alone.
Results date posted
| 2020 | Year | 08 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Good
Participant flow
Good
Adverse events
None
Outcome measures
IOL location, refractive error
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 03 | Day |
Last modified on
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038332
