UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035993 |
|---|---|
| Receipt number | R000040999 |
| Scientific Title | Influence of capsular tension ring on intracapsular stability and visual function after implantation of multifocal intraocular lens |
| Date of disclosure of the study information | 2019/02/24 |
| Last modified on | 2023/08/29 10:13:16 |
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Basic information
Public title
Influence of capsular tension ring on intracapsular stability and visual function after implantation of multifocal intraocular lens
Acronym
CTR and multifocal intraocular lens
Scientific Title
Influence of capsular tension ring on intracapsular stability and visual function after implantation of multifocal intraocular lens
Scientific Title:Acronym
CTR and multifocal intraocular lens
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of capsular tension ring on surgery using multifocal intraocular lens
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stability of intraocular lens 3 months after surgery
Key secondary outcomes
Visual function 3 months after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cataract surgery without capsular tension ring
Interventions/Control_2
Cataract surgery with capsular tension ring
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
Patients with bilateral cataract
Key exclusion criteria
Eyes with other ocular diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Oshika |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Opohthalmology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3148
oshika@eye.ac
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Oshika |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Ophthalmology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3148
Homepage URL
oshika@eye.ac
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Sugita Eye Clinic, Miyoshi Eye Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sugita Eye Clinic, Miyoshi Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennoudai,Tsukuba, Ibaraki
Tel
0298533148
oshika@eye.ac
Secondary IDs
Secondary IDs
YES
Study ID_1
H30-297
Org. issuing International ID_1
University of Tsukuba
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
杉田眼科（東京都），三好眼科（広島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
https://journals.lww.com/jcrs/pages/articleviewer.aspx?year=2023&issue=04000&article=00012&type=Full
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/jcrs/pages/articleviewer.aspx?year=2023&issue=04000&article=00012&type=Full
Number of participants that the trial has enrolled
22
Results
Throughout the 12-month follow-up period, there was no significant difference in refractive and visual outcomes between groups. The amount of IOL decentration was significantly larger in eyes with CTR. There was a significant negative correlation between capsular bag diameter and the amount of IOL decentration in eyes with CTR, but not in eyes without CTR. CTR coimplantation increased IOL decentration possibly due to the interference between CTR eyelets and IOL haptics.
Results date posted
| 2023 | Year | 08 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with bilateral cataract
Participant flow
patients at the outpatient clinic
Adverse events
none
Outcome measures
clinical outcomes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 29 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 29 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 24 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040999
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