Prospective observational multicenter study to evaluate the stability and quality of the visual function after the implantation of OptiBlue (ZCB00V)
- Conditions
- Patients implanted with ZCB00V for the improvement of visual acuity of aphakic eye
- Registration Number
- JPRN-UMIN000009929
- Lead Sponsor
- Abbott Medical Optics Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 800
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method