UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009929 |
|---|---|
| Receipt number | R000011531 |
| Scientific Title | Prospective observational multicenter study to evaluate the stability and quality of the visual function after the implantation of OptiBlue (ZCB00V) |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2013/02/01 15:29:36 |
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Basic information
Public title
Prospective observational multicenter study to evaluate the stability and quality of the visual function after the implantation of OptiBlue (ZCB00V)
Acronym
Multicenter observational study of OptiBlue
Scientific Title
Prospective observational multicenter study to evaluate the stability and quality of the visual function after the implantation of OptiBlue (ZCB00V)
Scientific Title:Acronym
Multicenter observational study of OptiBlue
Region
| Japan |
Condition
Condition
Patients implanted with ZCB00V for the improvement of visual acuity of aphakic eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the stability and quality of the visual function after the implantation of OptiBlue (ZCB00V) through a multicenter observational study
Basic objectives2
Others
Basic objectives -Others
The stability and quality of the visual function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Ophthalmic examination by physicians (manifest and auto refraction, uncorrected far visual acuity and corrected visual acuity)
2) Evaluation of the patient reported visual function using the Japanese version of VFQ-25
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 18 years or older
2) Patients whose postoperative corrected visual acuity is expected to be at least 0.7 or better
3) Patients requiring an intraocular lens of approximately +15 to +26 diopters
4) Patients who can understand and sign informed consent
5) Patients who can visit the study site and undergo the examination during the observational period
Key exclusion criteria
1) Patients who have known systemic pathology, ophthalmologic disease or the history of previous surgery that may potentially affect visual functions
2) Patients who have the history of previous corneal refractive surgery
3) Patients who have been implanted with a multifocal intraocular lens or toric lens
4) Patients who are taking or may take the medications that could potentially affect visual functions
5) Patients with severe lens opacity
6) Patients who have the abnormalities of lens capsule or zonule of Zinn due to the preoperative or intraoperative complications, and the abnormalities may potentially cause the incorrect positioning of the intraocular lens, which potentially affect visual functions
7) Patients who have the pupillary abnormalities including no response, pupillotonia, shape anomaly or the condition mydriatic action (pupil diameter of 4 mm or longer) is not observed in the crepuscule or dark situation
8) Patients who have an allergy to mydriatic agent
9) Other patients considered unsuited for the study by the investigators
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Komatsu |
Organization
Abbott Medical Optics Japan K.K.
Division name
Medical Strategy & Education
Zip code
Address
5-13-1, Toranomon, Minato-ku Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Abbott Medical Optics Japan K.K.
Division name
Medical Strategy & Education
Zip code
Address
5-13-1, Toranomon, Minato-ku Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Abbott Medical Optics Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Abbott Medical Optics Japan K.K.
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
Address
Tel
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
| 2013 | Year | 02 | Month | 01 | 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
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2013 | Year | 02 | Month | 01 | Day |
Last modified on
| 2013 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011531
