Evaluation of the Rotational Stability
Not Applicable
Completed
- Conditions
- Cataract
- Registration Number
- NCT03247751
- Lead Sponsor
- Nidek Co. LTD.
- Brief Summary
To evaluate rotational stability of the investigational device implanted after cataract surgery.
- Detailed Description
The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
Inclusion Criteria
- Adults, 18 years or older
- Subject who diagnosed unilateral or bilateral age-related cataract.
- Potential postoperative BCVA of 0.2 log MAR (0.63) or better.
- Calculated IOL power in within the range of investigational IOL.
- Subject is able to understand, agree and sign the informed consent statement.
- Subject is able and willing to comply with the postoperative follow-up examination schedule.
Exclusion Criteria
- Uncontrolled systemic or ocular disease.
- Extremely shallow anterior chamber.
- Previous intraocular and corneal surgery.
- Traumatic cataract.
- Pregnancy or lactation.
- Concurrent participation in another drug and device clinical investigation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The intraocular lens rotation postoperative 6 months The angle of the intraocular rotation.
- Secondary Outcome Measures
Name Time Method visual acuity postoperative 6 months Distance BCVA
Adverse event postoperative 6 months severity and causal relationship
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