UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038961 |
|---|---|
| Receipt number | R000044427 |
| Scientific Title | 1-year postoperative changes in refraction, choroidal thickness, and axial length after implantation of two types of IOLs: a randomized, double-masked, comparative study. |
| Date of disclosure of the study information | 2019/12/25 |
| Last modified on | 2026/03/04 12:10:14 |
* 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
Changes in refraction, choroidal thickness, and axial length after implantation of two types of intraocular lenses (IOLs)
Acronym
Changes in refraction, choroidal thickness, and axial length after implantation of two types of IOLs
Scientific Title
1-year postoperative changes in refraction, choroidal thickness, and axial length after implantation of two types of IOLs: a randomized, double-masked, comparative study.
Scientific Title:Acronym
Postoperative changes in refraction, choroidal thickness, and axial length after implantation of two types of IOLs: a randomized, double-masked, comparative study.
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been shown that refraction, choroidal thickness, and axial length change after cataract surgery. We compare two types of IOLs to examine whether there are differences in postoperative changes in refraction, choroidal thickness, and axial length.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We will examine refraction, choroidal thickness, axial length before surgery, and at 3, 6, 9, 12, 24, 36, 48, 60, 72, 96, and 120 months after cataract surgery as primary outcomes.
Key secondary outcomes
We will examine visual acuity, corneal astigmatism, and foveal thickness before surgery and at 3, 6, 9, 12, 24, 36, 48, 60, 72, 96, and 120 months after cataract surgery as secondary outcomes.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
IOLs (AMO ZCB00V) is implanted.
Interventions/Control_2
IOLs (Santen W-60R) is implanted.
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
Patients who were to undergo cataract surgery and implantation of two types of IOLs (AMO ZCB00V and Santen W-60R).
Key exclusion criteria
1) eyes with macular diseases
2) eyes with previous history of choroidal disease (uveitis, central choroidal retinopathy)
3) Eyes with diabetic retinopathy
4) History of intraocular surgery
5) Intraoperative complications
6) Inability to measure preoperative choroidal thickness
7) Rejection of participation in study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | KEN |
| Middle name | |
| Last name | HAYASHI |
Organization
Hayashi Eye Hospital
Division name
Department of ophthalmology
Zip code
812-0011
Address
4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan
TEL
092-431-1680
hayashi-ken@hayashi.or.jp
Public contact
Name of contact person
| 1st name | KEN |
| Middle name | |
| Last name | HAYASHI |
Organization
Hayashi Eye Hospital
Division name
Department of ophthalmology
Zip code
812-0011
Address
4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan
TEL
092-431-1680
Homepage URL
hayashi-ken@hayashi.or.jp
Sponsor or person
Institute
Hayashi Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Keio University School of medicine
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional Review Board of Hayashi Eye Hospital
Address
4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan
Tel
092-431-1680
mihara-seiya@hayashi.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
林眼科病院（福岡県）/Hayashi Eye Hospital(Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2030 | Year | 01 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- To observe changes in refraction, choroidal thickness, and axial length after cataract surgery over the long term after implantation of two types of intraocular lenses, the observation period will be extended to 60 months after surgery.
- From 12 months onwards, the study will be open-label, meaning subjects will know which intraocular lens was implanted.
- The examination procedures will remain the same as before.
- Additional examination periods will be added at 24, 36, 48, and 60 months after surgery.
- For examinations to be conducted after 12 months after surgery, subjects will be given a written explanation and their consent will be obtained using a consent form to confirm their intention to participate in the study.
The following is an update from March 4, 2026.
- The observation period will be extended to 120 months after surgery.
- Additional examination periods will be added at 72, 96, and 120 months in addition to the 60-month period mentioned above.
-For extensions beyond the 60th month, an explanatory document will be provided to confirm whether or not participants wish to continue participating in the study, and consent will be obtained.
Management information
Registered date
| 2019 | Year | 12 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044427
