UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045795 |
|---|---|
| Receipt number | R000051801 |
| Scientific Title | prospective observation for the patients with DCB00 or ICB00 implantation |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2023/09/15 12:50:28 |
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Basic information
Public title
prospective observation for the patients with DCB00 or ICB00 implantation
Acronym
prospective observation of DCB or ICB
Scientific Title
prospective observation for the patients with DCB00 or ICB00 implantation
Scientific Title:Acronym
prospective observation of DCB or ICB
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to survey visual acuity and satisfaction after implantation DCB00 or ICB00
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
uncorrected visual acuity(far, intermediate, near)
corrected visual acuity(far, intermediate, near)
Key secondary outcomes
glass wear, questionnaire ,refraction
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
the patients underwent with cataract surgery at Japanese Red Cross Wakayama Medical Center
Key exclusion criteria
the patients who do not want to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ogino |
Organization
Japanese Red Cross Wakayama Medical Center
Division name
ophthalmology
Zip code
640-8558
Address
Komatsubara-dori 4-20, Wakayama city
TEL
0734224171
kenboo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Ogino |
Organization
Japanese Red Cross Wakayama Medical Center
Division name
ophthalmology
Zip code
640-8558
Address
Komatsubara-dori 4-20, Wakayama city
TEL
0734224171
Homepage URL
kenboo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Japanese Red Cross Wakayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Wakayama Medical 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
Japanese Red Cross Wakayama Medical Center
Address
Komatsubara-dori 4-20, Wakayama city
Tel
0734224171
0112sin@wakayama-med.jrc.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
| 2021 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051801
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051801
Number of participants that the trial has enrolled
93
Results
Intermediate visual acuity was better in the DIB group (p<0.01 in both eyes and p<0.01 in one eye), and near visual acuity was also better in the DIB group (p=0.01 in both eyes). (p=0.018 in both eyes, p<0.01 in one eye). Patient satisfaction was significantly better for DCB at intermediate distances (p=0.045), but there were no significant differences in either spectacle dependence or dysphotopsia.
Results date posted
| 2023 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were patients who underwent lens reconstruction in both eyes at the Department of Ophthalmology, Japanese Red Cross Wakayama Medical Center from October 2021 to April 2022.
Participant flow
The study subjects were patients aged 20 years or older who underwent lens reconstruction surgery at our hospital between October 2021 and April 2022. After the physician in charge explained the study to the patients, written consent was obtained. Exclusion criteria were macular disease, glaucoma including central visual field abnormality, previous internal ophthalmic surgery, apparent strabismus in the distance or near on the Cover-Uncover Test that would make binocular unification difficult after surgery, astigmatism with a cylinder power of -2.00 D or greater, and expected postoperative refraction value of -2.00 D or greater.
Adverse events
none
Outcome measures
The primary endpoints were one- and binocular naked eye visual acuity at distance (5 m) and intermediate (70 cm) and one- and binocular visual acuity at distance, intermediate, and near (30 cm) under full correction of distance vision at 3 months postoperatively.
First, after measuring the other-sensory refraction values using TONOREF2 (NIDEK), the distance naked eye visual acuity and intermediate visual acuity were measured. Then, using the lens exchange method with reference to the other refraction values, the distance fully corrected visual acuity was measured, and the obtained refraction values were used to measure intermediate and near visual acuity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 30 | Day |
Other
Other related information
The reason for starting the entry one and a half month in advance is that we currently perform the surgery about two weeks after the application for the cataract surgery, so we expect to be able to enter the target number of subjects before and after the lens change. It is expected that the target number of patients will be able to enter before and after the lens change. The subjects will be fully explained about this study both orally and in a written explanation, and written consent will be obtained. For patients whose consent has been obtained, the medical record will be used to obtain information on the patient's age, gender, intraocular lenses used, preoperative and intraoperative complications, and visual acuity and refraction before and after surgery (3 months+-2 weeks after surgery). In addition, we will conduct a questionnaire survey on the wearing of glasses before and after surgery and postoperative subjective symptoms.
Management information
Registered date
| 2021 | Year | 10 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051801
