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

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

Study Overview

• Status: Unknown
• Conditions: Presbyopia
• Intervention / Treatment: Device: SAV

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tae-Young Chung, PhD; Phone Number: 82-2-3410-3548; Email: taeyoung15.chung@samsung.com
• Study Contact Backup: Name: Dong Hui Lim, PhD; Phone Number: 82-2-3410-3548; Email: ldhlse@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SAV multifocal IOL; Subjects who have cataract surgery with SAV multifocal IOL	Device: SAV; SAV multifocal intraocular lens is a implantable IOL which offers multifocal vision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected distant visual acuity	Visual acuity at distance with bare eyes	3 months
Uncorrected near visual acuity	Visual acuity at near with bare eyes	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity	Ability to recognize letter or figure at different contrast environment	3 months
Quality of Vision	Degree of various symptom associated with vision	3 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Chair: Tae-Young Chung, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Anticipated): January 22, 2021
• Study Completion (Anticipated): January 22, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: depth and focus
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 2019-12-019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No