Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens
| Registry | NCT03247751 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 95 (Actual) |
| Sponsor | Nidek Co. LTD. (Industry) |
| Conditions | Cataract |
| Interventions | intraocular lens (Device) |
| Dates | start 2016-06-01, primary completion 2017-08-01, completion 2017-11-01, first posted 2017-08-14, last updated 2023-06-07 |
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To evaluate rotational stability of the investigational device implanted after cataract surgery.
The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| one group | Experimental | Device: intraocular lens | one group receiving NIDEK intraocular lens |
Sex: All, ages: 18 Years to any
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.