Evaluation of the Rotational Stability

N/ACompletedNCT03247751

Nidek Co. LTD.95 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract

Interventions

intraocular lensDEVICE

Implant NIDEK intraocular lens after cataract surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The intraocular lens rotation

The angle of the intraocular rotation.

Time frame: postoperative 6 months

Secondary Outcomes

visual acuity

Distance BCVA

Time frame: postoperative 6 months

Adverse event

severity and causal relationship

Time frame: postoperative 6 months

Data from ClinicalTrials.gov

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