UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046987 |
|---|---|
| Receipt number | R000053610 |
| Scientific Title | Simple surgical technique for accurate implantation of toric intraocular lenses |
| Date of disclosure of the study information | 2022/02/24 |
| Last modified on | 2022/02/24 12:23:31 |
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Basic information
Public title
Simple surgical technique for accurate implantation of toric intraocular lenses
Acronym
Simple technique for implantation of toric intraocular lens
Scientific Title
Simple surgical technique for accurate implantation of toric intraocular lenses
Scientific Title:Acronym
Simple technique for implantation of toric intraocular lens
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the degree of toric IOL rotation during OVD removal using conventional surgical technique and the degree of toric IOL rotation using current technique.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Images taken before and after removal of OVD are captured from the recorded video. A reference line is determined by connecting two critical details, and another line is determined by joining two details on the IOL. The angle at intersection of these two lines is measured, and the difference in the angles before and after OVD removal was defined as the angle of rotation.
The angle of rotation during OVD removal using the current technique and conventional technique are compared. The angle of rotation using conventional technique is published in previous study.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who underwent cataract surgery with implantation of toric IOL using the current technique.
Key exclusion criteria
Patients deemed inappropriate by the principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Ohashi |
Organization
Medical Corporation Ohashi Eye Center
Division name
President
Zip code
003-0027
Address
Kita 1-1 Hondori 6, Shiroishi, Sapporo, 003-0027 Japan
TEL
011-864-4656
ohashi@rainbow.ne.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Ohashi |
Organization
Medical Corporation Ohashi Eye Center
Division name
President
Zip code
003-0027
Address
Kita 1-1 Hondori 6, Shiroishi, Sapporo, 003-0027 Japan
TEL
011-864-4656
Homepage URL
ohashi@rainbow.ne.jp
Sponsor or person
Institute
Medical Corporation Ohashi Eye Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Chukyo Eye Clinic, REC
Address
12-23 Sanbonmatsu-cho Atsuta-ku, Nagoya city Aichi
Tel
052-884-7976
irb@chukyomedical.co.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
| 2022 | Year | 02 | Month | 24 | 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
20
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The conventional surgical technique using OVD, IOL is inserted into capsular bag filled with OVD, adjust the position of the IOL, and then remove the OVD. In this method, the IOL rotates during removal of the OVD and needs to be readjusted.
With the new technique, after inserting of toric IOL, OVD is injected above the IOL and BSS is injected under the OVD. IOL is rotated to the final position and the OVD is removed.
Management information
Registered date
| 2022 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053610
