Clinical Outcome of Extended-depth-of-focus Intraocualr Lens (SAV) Implantation

NCT ID: NCT04391972

Last Updated: 2020-05-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-11

Study Completion Date

2021-01-22

Brief Summary

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Clinical outcome of extended-depth-of-focus intraocular lens (SAV) implantation

Detailed Description

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In this study, we are trying to evaluate the clinical outcome of extended-depth-of-focus intraocular lens (SAV).

Conditions

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Presbyopia

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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SAV multifocal IOL

Subjects who have cataract surgery with SAV multifocal IOL

Group Type OTHER

SAV

Intervention Type DEVICE

SAV multifocal intraocular lens is a implantable IOL which offers multifocal vision.

Interventions

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SAV

SAV multifocal intraocular lens is a implantable IOL which offers multifocal vision.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
2. Age-related cataract
3. A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
4. A patient want presbyopia correction at the same time as cataract surgery
5. A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
6. Written informed consent to surgery and participation in the study

Exclusion Criteria

1. Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
2. Pregnant woman and lactating woman
3. A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
4. A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
5. If expectations for presbyopia correction are too high
6. Those who are not able to read and understand the informed consent (illiterate or foreigners)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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tae-young chung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Young Chung, PhD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Tae-Young Chung, PhD

Role: CONTACT

82-2-3410-3548

Dong Hui Lim, PhD

Role: CONTACT

82-2-3410-3548

Facility Contacts

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Tae-Young Chung

Role: primary

+82-10-9933-3563

Other Identifiers

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2019-12-019

Identifier Type: -

Identifier Source: org_study_id

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