UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024986 |
|---|---|
| Receipt number | R000028728 |
| Scientific Title | Randomized prospective study on refraction error in cataract vitrectric simultaneous surgery |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2016/11/24 22:58:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized prospective study on refraction error in cataract vitrectric simultaneous surgery
Acronym
Randomized prospective study on refraction error in cataract vitrectric simultaneous surgery
Scientific Title
Randomized prospective study on refraction error in cataract vitrectric simultaneous surgery
Scientific Title:Acronym
Randomized prospective study on refraction error in cataract vitrectric simultaneous surgery
Region
| Japan |
Condition
Condition
Epiretinal membrane. Macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the target refractive error for one-piece intraocular lens and three piece intraocular lens insertion for the Epiretinal membrane and the macular hole, which is an indication for vitreous surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative refraction and visual acuity change
Changes in anterior chamber depth after surgery
Changes in intraocular pressure after surgery
Changes in intraventricular inflammation after surgery
One week, one month, three months, six months, one year after surgery
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
Postoperative refraction error when 1-piece intraocular lens is inserted in simultaneous operation of cataract vitreous body
Interventions/Control_2
Postoperative refraction error when 3-piece intraocular lens is inserted in simultaneous operation of cataract vitreous body
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 went to the ophthalmology department of Wakayama Medical University Hospital for ophthalmology or who is hospitalized and who undergoes vitreous surgery combined with cataract surgery, and explained the content of the research with the document and verbally acknowledged in writing. The target disease is the Epiretinal Membrane and macular hole.
Key exclusion criteria
Those who have not undergone surgery before this surgery
Persons judged by the attending physician to be inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayoshi Sumioka |
Organization
Wakayama medical university
Division name
Department of opthalmology
Zip code
Address
811-1 kimiidera,wakayama
TEL
0734472300
sumioka@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Inoue |
Organization
Wakayama medical university
Division name
Department of opthalmology
Zip code
Address
811-1 kimiidera,wakayama
TEL
0734472300
Homepage URL
ainoue@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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | 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
Suspended
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | 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
| 2016 | Year | 11 | Month | 24 | Day |
Last modified on
| 2016 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028728
