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

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Samsung Medical Center

Status

Unknown

Conditions

Presbyopia

Treatments

Device: SAV

Study type

Interventional

Funder types

Other

Identifiers

NCT04391972
2019-12-019

Details and patient eligibility

About

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

Full description

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

Enrollment

25 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

SAV multifocal IOL
Other group
Description:
Subjects who have cataract surgery with SAV multifocal IOL
Treatment:
Device: SAV

Trial contacts and locations

1

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Central trial contact

Dong Hui Lim, PhD; Tae-Young Chung, PhD

Data sourced from clinicaltrials.gov

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