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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04391972
• Other study ID #: 2019-12-019
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2020
• Est. completion date: January 22, 2021

Study information

• Verified date: May 2020
• Source: Samsung Medical Center
• Contact: Tae-Young Chung, PhD
• Phone: 82-2-3410-3548
• Email: taeyoung15.chung[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Presbyopia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected distant visual acuity	Visual acuity at distance with bare eyes	3 months
Primary	Uncorrected near visual acuity	Visual acuity at near with bare eyes	3 months
Secondary	Contrast sensitivity	Ability to recognize letter or figure at different contrast environment	3 months
Secondary	Quality of Vision	Degree of various symptom associated with vision	3 months