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

Not Applicable

• Conditions: Presbyopia
• Interventions: Device: SAV

• Registration Number: NCT04391972
• Lead Sponsor: Samsung Medical Center

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).

Study Timeline

• Study Start: 2020-02-11
• Status Verified: 2020-05
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-15
• Last Update Submitted: 2020-05-15
• Study First Posted: 2020-05-18
• Last Update Posted: 2020-05-18
• Primary Completion: 2021-01-22
• Study Completion: 2021-01-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAV multifocal IOL	SAV	Subjects who have cataract surgery with SAV multifocal IOL

Primary Outcome Measures

Name	Time	Method
Uncorrected near visual acuity	3 months	Visual acuity at near with bare eyes
Uncorrected distant visual acuity	3 months	Visual acuity at distance with bare eyes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of