UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022388 |
|---|---|
| Receipt number | R000025801 |
| Scientific Title | Randomized prospective study related to errors in the prediction of postoperative refraction following intraocular lens implantation with exfoliation syndrome |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2020/12/08 10:50:55 |
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Basic information
Public title
Randomized prospective study related to errors in the prediction of postoperative refraction following intraocular lens implantation with exfoliation syndrome
Acronym
Randomized prospective study related to errors in the prediction of postoperative refraction following intraocular lens implantation with exfoliation syndrome
Scientific Title
Randomized prospective study related to errors in the prediction of postoperative refraction following intraocular lens implantation with exfoliation syndrome
Scientific Title:Acronym
Randomized prospective study related to errors in the prediction of postoperative refraction following intraocular lens implantation with exfoliation syndrome
Region
| Japan |
Condition
Condition
exfoliation syndrome, cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider the refractive error between one-piece intraocular lens and three-piece intraocular lens in patients following cataract surgery accompanied by exfoliation syndrome
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative refractive error between one-piece intraocular lens and three-piece intraocular lens
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Patients with exfoliation syndrome undergo cataract surgery and are implanted one-piece intraocular lens.
Interventions/Control_2
Patients with exfoliation syndrome undergo cataract surgery and are implanted three-piece intraocular lens.
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
Patient who obtained the consent of the free will of the patient himself for this clinical research.
For patients with dementia, we get the consent from alternate (consort, children, grandson, brother, sister).
Key exclusion criteria
patients who underwent eye surgery previously
patients who deemed inappropriate by attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Ishikawa |
Organization
Wakayama Medical University
Division name
Department of Ophthalmology
Zip code
6410012
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
niskw@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Ishikawa |
Organization
Wakayama Medical University
Division name
Department of Ophthalmology
Zip code
6410012
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
Homepage URL
niskw@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1 Kimiidera, Wakayama
Tel
073-447-2300
wa-rinri@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 20 | Day |
Last modified on
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025801
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
