UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029703 |
|---|---|
| Receipt number | R000033940 |
| Scientific Title | Silicone microtube assisted scleral fixation of a posterior chamber intraocular lens |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2017/10/25 11:49:35 |
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Basic information
Public title
Silicone microtube assisted scleral fixation of a posterior chamber intraocular lens
Acronym
Posterior chamber IOL scleral fixation
Scientific Title
Silicone microtube assisted scleral fixation of a posterior chamber intraocular lens
Scientific Title:Acronym
Posterior chamber IOL scleral fixation
Region
| Japan |
Condition
Condition
Aphakia, IOL dislocation, IOL opacity
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of scleral fixation of IOL assisted by a flexible slicone microtube which does not require the difficult intraocular procedure and does not damage the IOL or eye tissue.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual acuity (post operation:1 week, 1 month, 3 months, 6 months, and 1 year)
Key secondary outcomes
Intraocular pressure, refractive error, ophthalmoscopy, slit-lamp biomicroscopy (post operation:1 week, 1 month, 3 months, 6 months, and 1 year)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
IOL scleral fixation using a silicone microtube is performed on the subjects.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Planned patients for IOL scleral fixation
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiro Kamei |
Organization
Aichi Medical University
Division name
Department of Ophthalmology
Zip code
Address
1-1 KarimataYazako, Nagakute, Aichi, 480-1195 JAPAN
TEL
0561-62-3311
motokamei@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Kataoka |
Organization
Aichi Medical University
Division name
Department of Ophthalmology
Zip code
Address
1-1 KarimataYazako, Nagakute, Aichi, 480-1195 JAPAN
TEL
0561-62-3311
Homepage URL
kataoka.takuya.401@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Department of Ohthalmology
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
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
愛知医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | 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
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2017 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033940
