UMIN-CTR Clinical Trial

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

Patients implanted with ZCB00V for the improvement of visual acuity of aphakic eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

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

Email

Institute

Abbott Medical Optics Japan K.K.

Institute

Department

Personal name

Organization

Abbott Medical Optics Japan K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Prospective observational study

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