UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051907 |
|---|---|
| Receipt number | R000059142 |
| Scientific Title | Visual function of eyes implanted with non-diffractive extended depth of focus intraocular lens |
| Date of disclosure of the study information | 2023/08/14 |
| Last modified on | 2023/08/14 22:00:18 |
* 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
Visual function of eyes implanted with non-diffractive extended depth of focus intraocular lens
Acronym
Visual function of non-diffractive EDOF IOL
Scientific Title
Visual function of eyes implanted with non-diffractive extended depth of focus intraocular lens
Scientific Title:Acronym
Visual function of non-diffractive EDOF IOL
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the visual function of Japanese eyes implamted with non-diffractive extended depth of focus intraocular lens 3 years postoperatively
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Binocular best corrected visual acuity (5m) at 3 months postoperatively
Key secondary outcomes
Visual acuity at 3 months postoperatively
1) Monocular uncorrected visual acuity (5m, 66cm, 40cm)
2) Monocular distance corrected visual acuity (5m, 66cm, 40cm)
3) Binocular uncorrected visual acuity (5m, 66cm, 40cm)
4) Binocular distance corrected visual acuity (66cm, 40cm)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with bilateral age-related cataracts who are scheduled to have Clareon Vivity inserted in both eyes
(2) Patients with preoperative corneal astigmatism of 0.75 D or less in both eyes
(3) Patients who can expect a post-operative distance-corrected decimal visual acuity of 0.7 or better in one eye.
Key exclusion criteria
(1) Patients with conditions other than cataract that may affect the endpoints
(2) Patients with corneal irregular astigmatism
(3) Patients with a history of corneal refractive surgery, intraocular surgery and corneal surgery
(4) Patients who are judged to be inappropriate by the principal investigator or a sub-investigator because of other systemic or ophthalmological diseases.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Bissen |
Organization
Tokyo Dental College Suidobashi Hospital
Division name
Department of Ophthalmology
Zip code
101-0061
Address
2-9-18, Kandamisaki-cho, Chiyoda-ku
TEL
03-5275-1856
bissen@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Ota |
Organization
Tokyo Dental College Suidobashi Hospital
Division name
Department of Ophthalmology
Zip code
101-0061
Address
2-9-18, Kandamisaki-cho, Chiyoda-ku
TEL
03-5275-1856
Homepage URL
yota@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NPO MINS
Address
#2, 1-15-14, Dogenzaka, Shibuya-ku
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
YES
Study ID_1
JCS#86884787
Org. issuing International ID_1
NPO MINS
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京歯科大学水道橋病院（東京都）、医療法人メビア 戸塚駅前鈴木眼科（神奈川県）、善行すずき眼科（神奈川県）、スカイビル眼科医院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No concomitant prohibited therapies are set.
Management information
Registered date
| 2023 | Year | 08 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059142
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
