Evaluation of the Rotational Stability

NCT ID: NCT03247751

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-11-30

Brief Summary

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

Detailed Description

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

Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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one group

one group receiving NIDEK intraocular lens

Group Type EXPERIMENTAL

intraocular lens

Intervention Type DEVICE

Implant NIDEK intraocular lens after cataract surgery

Interventions

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intraocular lens

Implant NIDEK intraocular lens after cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nidek Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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BPF001C

Identifier Type: -

Identifier Source: org_study_id

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