UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037098 |
|---|---|
| Receipt number | R000042264 |
| Scientific Title | Comparison of the position of steep meridian by image guiding system (Verion) and manual marking technique. |
| Date of disclosure of the study information | 2019/06/18 |
| Last modified on | 2020/12/17 14:45:30 |
* 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
Comparison of the position of steep meridian by image guiding system (Verion) and manual marking technique.
Acronym
Examination of image guiding system's (Verion) effectiveness
Scientific Title
Comparison of the position of steep meridian by image guiding system (Verion) and manual marking technique.
Scientific Title:Acronym
Examination of image guiding system's (Verion) effectiveness
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve uncorrected visual acuity marking accurate Toric IOL implant position is essential in cataract surgery. Conventional manual marking technique and new image guiding system (Verion) were used to mark the Toric IOL position and its errors were measured preoperatively and compared.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preoperatively in the office difference of reference point which was decided manually under the slitlamp and 90 degrees position by image guiding system were measured and ratio of under 5 degrees and 10 degrees were calculated respectively. Then, difference between steep meridian decided manually and by image guiding system (Verion) were measured preoperatively and postoperatively. Ratio of errors under 5 degrees and 10 degrees are calculated respectively.
Preoperative and postoperative visual acuity, refractive examination value, corneal astigmatism, and toric axis rotational error were assessed.
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
| 19 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Within cataract patient with over 2.5D corneal astigmatism, patient who went through a surgery with manual marking and image guiding system.
Key exclusion criteria
Patient with intraoperative or postoperative complication, amblyopia, maculopathy, glaucoma, or uveitis which affects visual acuity.
Target sample size
100
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
6 Cho-me kita 1-1 Hondori Shiroishi-ku Sapporo city
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
6 Cho-me kita 1-1 Hondori Shiroishi-ku Sapporo city
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
Medical Corporation Ohashi Eye Center
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
6F Chukyo Bldg. 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
| 2019 | Year | 06 | Month | 18 | 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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To improve uncorrected visual acuity marking accurate Toric IOL implant position is essential in cataract surgery. Conventional manual marking technique and new image guiding system (Verion) were used to mark the Toric IOL position and its errors were measured preoperatively and compared.
Preoperatively in the office difference of reference point which was decided manually under the slitlamp and 90 degrees position by image guiding system were measured and ratio of under 5 degrees and 10 degrees were calculated respectively. Then, difference between steep meridian decided manually and by image guiding system (Verion) were measured preoperatively and postoperatively. Ratio of errors under 5 degrees and 10 degrees are calculated respectively.
Preoperative and postoperative visual acuity, refractive examination value, corneal astigmatism, and toric axis rotational error were assessed.
Management information
Registered date
| 2019 | Year | 06 | Month | 18 | Day |
Last modified on
| 2020 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042264
