UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039265 |
|---|---|
| Receipt number | R000044780 |
| Scientific Title | Multicenter comparative study of toric intraocular lens implantation using an image guide system |
| Date of disclosure of the study information | 2020/01/27 |
| Last modified on | 2022/08/10 11:26:47 |
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Basic information
Public title
Multicenter comparative study of toric intraocular lens implantation using an image guide system
Acronym
Multicenter comparative study of toric intraocular lens implantation using an image guide system
Scientific Title
Multicenter comparative study of toric intraocular lens implantation using an image guide system
Scientific Title:Acronym
Multicenter comparative study of toric intraocular lens implantation using an image guide system
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Toric intraocular lens used in cataract surgery can acquire good uncorrected visual acuity after surgery by correcting corneal astigmatism. In order to obtain good results in toric IOL implantation, accuracy of preoperative examination, toric model selection, control of induced astigmatism in surgery, and accurate implantation of IOL are important. In particular, toric IOL needs to be fixed to the astigmatic axis, and it it's off axis by 3 degrees, it loses about 3.3% of the refractive correction effect. Therefore, when the axis is shifted by 30 degrees, astigmatic correction effect is completely lost, and only the astigmatic axis may change.
Conventionally, using a surgical pen, marking is performed at 0, 3, 6, 9 and 12 o'clock position with a slit lamp microscope before surgery, and fixed position is measured intraoperatively from that position, then toric IOL was implanted. The image guide system is a system that digitizes this technique and refers to anterior segment information photographed in a sitting position before surgery, and displays an accurate toric IOL fixation axis intraoperatively. Shortening of operation time, reduction of human error, and improvement of postoperative axis deviation can be expected.
Currently, number of cases of toric IOL implantation are increasing, but until now it has been mostly studied in a single center, and less from multiple centers. The purpose of this study is to investigate prospectively the results after toric IOL implantation as a multi-institutional collaborative study, and to determine whether there is a difference between institutions.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to evaluate prospective outcomes after toric IOL implantation as a multi-institutional cooperative study and evaluate postoperative outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative
-visual acuity, subjective and objective refraction
-corneal shape analysis by anterior segment OCT
Key secondary outcomes
Patients' background such as
-age
-sex
-cataract nucleus hardness classification (Emery-Little classification)
-disease type of cataract (WHO classification, nucleus, cortex, under posterior capsule)
-preoperative visual acuity
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
-over 20 years old
-does not have ocular disease other than cataract or refractive error
-case without intraoperative complication
Key exclusion criteria
-being pregnant, lactating
-brittle Zinn's zonule
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kojima |
Organization
Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL
052-883-1543
kojima@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kojima |
Organization
Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL
052-883-1543
Homepage URL
kojima@chukyogroup.jp
Sponsor or person
Institute
Chukyo Eye Clinic
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 Medical IRB
Address
12-23 Sanbonmatsu-cho Atsuta-ku, Nagoya 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
医療法人いさな会 中京眼科(愛知県)
名古屋アイクリニック(愛知県)
医療法人桑友会 佐藤裕也眼科医院（宮城県）
岐阜赤十字病院（岐阜県）
医療法人宝美会 総合青山病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
none
Publication of results
Partially published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
137
Results
referring to a meeting abstract of the 60th Annual Meeting of JSCR
Results date posted
| 2022 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
referring to a meeting abstract of the 60th Annual Meeting of JSCR
Participant flow
referring to a meeting abstract of the 60th Annual Meeting of JSCR
Adverse events
referring to a meeting abstract of the 60th Annual Meeting of JSCR
Outcome measures
referring to a meeting abstract of the 60th Annual Meeting of JSCR
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Toric intraocular lens used in cataract surgery can acquire good uncorrected visual acuity after surgery by correcting corneal astigmatism. In order to obtain good results in toric IOL implantation, accuracy of preoperative examination, toric model selection, control of induced astigmatism in surgery, and accurate implantation of IOL are important. In particular, toric IOL needs to be fixed to the astigmatic axis, and it it's off axis by 3 degrees, it loses about 3.3% of the refractive correction effect. Therefore, when the axis is shifted by 30 degrees, astigmatic correction effect is completely lost, and only the astigmatic axis may change.
Conventionally, using a surgical pen, marking is performed at 0, 3, 6, 9 and 12 o'clock position with a slit lamp microscope before surgery, and fixed position is measured intraoperatively from that position, then toric IOL was implanted. The image guide system is a system that digitizes this technique and refers to anterior segment information photographed in a sitting position before surgery, and displays an accurate toric IOL fixation axis intraoperatively. Shortening of operation time, reduction of human error, and improvement of postoperative axis deviation can be expected.
Currently, number of cases of toric IOL implantation are increasing, but until now it has been mostly studied in a single center, and less from multiple centers. The purpose of this study is to investigate prospectively the results after toric IOL implantation as a multi-institutional collaborative study, and to determine whether there is a difference between institutions.
Management information
Registered date
| 2020 | Year | 01 | Month | 27 | Day |
Last modified on
| 2022 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044780
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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