UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055208 |
|---|---|
| Receipt number | R000058285 |
| Scientific Title | 1 year Clinical evaluation of visual functions with Clareon PanOptix |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/08/09 16:45:58 |
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Basic information
Public title
1 year Clinical evaluation of visual functions with Clareon PanOptix
Acronym
1 year Clinical evaluation of visual functions with Clareon PanOptix
Scientific Title
1 year Clinical evaluation of visual functions with Clareon PanOptix
Scientific Title:Acronym
1 year Clinical evaluation of visual functions with Clareon PanOptix
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Clareon PanOptix/Clareon Panoptix Toric at 1 year in Japanese patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
binocular best corrected visual acuity (5m) at 12 months post-op
Key secondary outcomes
Visual acuity (5 m, 60 cm, 40 cm) :1 month, 6 months, 12 months after surgery
Uncorrected monocular visual acuity
Monocular distance corrected visual acuity
Binocular uncorrected visual acuity
Binocular distance-corrected visual acuity
Quality of Life Questionnaire preoperative, 1, 6, and 12 months postoperative
Refractive error at 1, 6, and 12 months postoperatively
Evaluate the degree of safety information if any of the following are observed
Gristining at 1, 6, and 12 months postoperatively
Posterior cataracts at 1, 6, and 12 months postoperatively
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
Binocular Age related Cataract patients scheduled to insert Clareon PanOptix/ Clareon PanOptix Toric (T2-T6) in both eyes
Normal range of Axial lengths biometry from 22.0 mm to 26.5 mm (no long/short eyes)
Patients expected to visit the site until 12 months after surgery
Key exclusion criteria
Any disease (patients with retinal disease, glaucoma or dry eye) that affects endpoints other than cataract
Corneal irregular astigmatism
Previous intraocular or refractive surgery
Disqualified by the investigator because of physical or ophthalmic diseases
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Fujita |
Organization
Fujita Eye Clinic
Division name
None
Zip code
7700026
Address
6-27Sako6 TokusihimaCity Tokusihima Prefecture Japan
TEL
0886561010
yoshifumi@fujitaec.or.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Itami |
Organization
Fujita Eye Clinic
Division name
None
Zip code
7700026
Address
6-27 Sako Rokubanncho Tokusihima City Tokusihima Prefecture Japan
TEL
0886561010
Homepage URL
itami@fujitaec.or.jp
Sponsor or person
Institute
Fujita Eye Clinic
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
MINS
Address
20-9-401 Mita 5Chome Minato-ku Tokyo
Tel
0364161868
npo-mins@j-irb.com
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
| 2024 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 08 | Month | 09 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058285
