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Prospective observational multicenter study to evaluate the stability and quality of the visual function after the implantation of OptiBlue (ZCB00V)

Prospective observational multicenter study to evaluate the stability and quality of the visual function after the implantation of OptiBlue (ZCB00V) - Multicenter observational study of OptiBlue

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000009929
Enrollment
800
Registered
2013-02-01
Start date
2013-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

Abbott Medical Optics Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026