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

Primary Purpose

Presbyopia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SAV
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring depth and focus

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SAV multifocal IOL

Arm Description

Subjects who have cataract surgery with SAV multifocal IOL

Outcomes

Primary Outcome Measures

Uncorrected distant visual acuity
Visual acuity at distance with bare eyes
Uncorrected near visual acuity
Visual acuity at near with bare eyes

Secondary Outcome Measures

Contrast sensitivity
Ability to recognize letter or figure at different contrast environment
Quality of Vision
Degree of various symptom associated with vision

Full Information

First Posted
May 15, 2020
Last Updated
May 15, 2020
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04391972
Brief Title
Clinical Outcome of Extended-depth-of-focus Intraocualr Lens (SAV) Implantation
Official Title
Clinical Outcome of Extended-depth-of-focus Intraocualr Lens (SAV) Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
January 22, 2021 (Anticipated)
Study Completion Date
January 22, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Clinical outcome of extended-depth-of-focus intraocular lens (SAV) implantation
Detailed Description
In this study, we are trying to evaluate the clinical outcome of extended-depth-of-focus intraocular lens (SAV).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
depth and focus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAV multifocal IOL
Arm Type
Other
Arm Description
Subjects who have cataract surgery with SAV multifocal IOL
Intervention Type
Device
Intervention Name(s)
SAV
Intervention Description
SAV multifocal intraocular lens is a implantable IOL which offers multifocal vision.
Primary Outcome Measure Information:
Title
Uncorrected distant visual acuity
Description
Visual acuity at distance with bare eyes
Time Frame
3 months
Title
Uncorrected near visual acuity
Description
Visual acuity at near with bare eyes
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Contrast sensitivity
Description
Ability to recognize letter or figure at different contrast environment
Time Frame
3 months
Title
Quality of Vision
Description
Degree of various symptom associated with vision
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Age-related cataract A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters A patient want presbyopia correction at the same time as cataract surgery A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation Written informed consent to surgery and participation in the study Exclusion Criteria: Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract Pregnant woman and lactating woman A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye If expectations for presbyopia correction are too high Those who are not able to read and understand the informed consent (illiterate or foreigners)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Young Chung, PhD
Phone
82-2-3410-3548
Email
taeyoung15.chung@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Hui Lim, PhD
Phone
82-2-3410-3548
Email
ldhlse@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Young Chung, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-Young Chung
Phone
+82-10-9933-3563
Email
tychung@skku.edu

12. IPD Sharing Statement

Learn more about this trial

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

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