Evaluation of the Rotational Stability

Nidek

Status: Completed

Conditions: Cataract

Treatments: Device: intraocular lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT03247751

BPF001C

Details and patient eligibility

About

To evaluate rotational stability of the investigational device implanted after cataract surgery.

Full description

The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

95 participants in 1 patient group

one group

Experimental group

Description:

one group receiving NIDEK intraocular lens

Treatment:

Device: intraocular lens