Clinical Outcome of Extended-depth-of-focus Intraocualr Lens (SAV) Implantation
1 other identifier
interventional
25
1 country
1
Brief Summary
Clinical outcome of extended-depth-of-focus intraocular lens (SAV) implantation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2020
CompletedFirst Submitted
Initial submission to the registry
May 15, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2021
CompletedMay 18, 2020
May 1, 2020
12 months
May 15, 2020
May 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Contrast sensitivity
3 months
Quality of Vision
3 months
Study Arms (1)
SAV multifocal IOL
OTHERSubjects who have cataract surgery with SAV multifocal IOL
Interventions
SAV multifocal intraocular lens is a implantable IOL which offers multifocal vision.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tae-Young Chung, PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 15, 2020
First Posted
May 18, 2020
Study Start
February 11, 2020
Primary Completion
January 22, 2021
Study Completion
January 22, 2021
Last Updated
May 18, 2020
Record last verified: 2020-05