UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049822 |
|---|---|
| Receipt number | R000056741 |
| Scientific Title | Intermediate distance visual acuity in the Clareon monofocal intraocular lenses |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2022/12/19 11:06:42 |
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Basic information
Public title
Intermediate distance visual acuity in the Clareon monofocal intraocular lenses
Acronym
Intermediate distance visual acuity in the Clareon monofocal intraocular lenses
Scientific Title
Intermediate distance visual acuity in the Clareon monofocal intraocular lenses
Scientific Title:Acronym
Intermediate distance visual acuity in the Clareon monofocal intraocular lenses
Region
| Japan |
Condition
Condition
pseudophakia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate visual function at 3 months postoperatively for Clareon /Clareon Toric
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Binocular best corrected distance visual acuity at 3 months after surgery
Key secondary outcomes
1.Binocular naked eye far visual acuity at 3 months after surgery
2.Binocular far-corrected intermediate visual acuity ( 80cm, 66cm) at 3 months after surgery
3.Binocular naked eye intermediate visual acuity ( 80cm, 66cm) at 3 months after surgery
4.Best corrected far visual acuity in one eye 3 months after surgery
5.Naked eye far visual acuity of one eye at 3 months after surgery
6.Postoperative intermediate distance-corrected visual acuity of one eye at 3 months ( 80cm, 66cm)
7.Naked eye intermediate visual acuity of one eye at 3 months after surgery ( 80cm, 66cm)
8.Defocused curves 3 months after surgery
9.Postoperative refractive error
10.Distribution of 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
1.Binocular age-related cataract patients
2.Men and women over 20 years old
3.Patients scheduled for bilateral Clareon or Clareon Toric insertions with positive vision in both eyes
4.Patients can expect postoperative distance-corrected visual acuity of 0.7 or better in one eye
Key exclusion criteria
1.Patients with ocular diseases affecting visual function other than cataract
2.Patients with corneal irregular astigmatism
3.Glaucoma patients
4.Patients with a history of corneal refractive surgery, endophthalmic surgery, and keratoplasty
5.Patients deemed inappropriate by the responsible physician or subspecialist due to systemic or ophthalmologic diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Iichiro |
| Middle name | |
| Last name | Sugita |
Organization
Medical Corporation Sugita Eye Hospital
Division name
Ophthalmology
Zip code
460-0008
Address
5-1-30 Sakae, Naka-ku, Nagoya City, Aichi
TEL
052-251-6571
iichiro@sugita.or.jp
Public contact
Name of contact person
| 1st name | Iichiro |
| Middle name | |
| Last name | Sugita |
Organization
Medical Corporation Sugita Eye Hospital
Division name
Ophthalmology
Zip code
460-0008
Address
5-1-30 Sakae, Naka-ku, Nagoya City, Aichi
TEL
052-251-6571
Homepage URL
iichiro@sugita.or.jp
Sponsor or person
Institute
Medical Corporation Sugita Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan K.K.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Sugita Eye Hospital of Medicine Ethics Committee
Address
5-1-30 Sakae, Naka-ku, Nagoya City, Aichi
Tel
052-251-6571
tadasu@sugita.or.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 | 12 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations
1.Binocular naked eye far visual acuity at 3 months after surgery
2.Binocular far-corrected intermediate visual acuity ( 80cm, 66cm) at 3 months after surgery
3.Binocular naked eye intermediate visual acuity ( 80cm, 66cm) at 3 months after surgery
4.Best corrected far visual acuity in one eye 3 months after surgery
5.Naked eye far visual acuity of one eye at 3 months after surgery
6.Postoperative intermediate distance-corrected visual acuity of one eye at 3 months ( 80cm, 66cm)
7.Naked eye intermediate visual acuity of one eye at 3 months after surgery ( 80cm, 66cm)
8.Defocused curves 3 months after surgery
9.Postoperative refractive error
10.Distribution of visual acuity
11.Binocular best corrected distance visual acuity at 3 months after surgery
Management information
Registered date
| 2022 | Year | 12 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056741
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