Status:
COMPLETED
Evaluation of the Rotational Stability
Lead Sponsor:
Nidek Co. LTD.
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03247751
Start Date
June 1 2016
End Date
November 1 2017
Last Update
June 7 2023
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