Cataract
Conditions
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.
Interventions
DEVICEintraocular lens
Implant NIDEK intraocular lens after cataract surgery
Sponsors
Nidek Co. LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The intraocular lens rotation | postoperative 6 months | The angle of the intraocular rotation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual acuity | postoperative 6 months | Distance BCVA |
| Adverse event | postoperative 6 months | severity and causal relationship |
Outcome results
None listed