PresbyopiaNCT04391972
Clinical Outcome of Extended-depth-of-focus Intraocualr Lens (SAV) Implantation
A study testing SAV in people with Presbyopia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Clinical outcome of extended-depth-of-focus intraocular lens (SAV) implantation Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- SAV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Feb 2020to 22 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Tae-Young Chung, +82-10-9933-3563, tychung@skku.edu
About this study
Clinical outcome of extended-depth-of-focus intraocular lens (SAV) implantation
Read the detailed description
In this study, we are trying to evaluate the clinical outcome of extended-depth-of-focus intraocular lens (SAV).
- Conditions
- Presbyopia
- Being tested
- SAV
- Keywords
- depth and focus
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAVDevice
SAV multifocal intraocular lens is a implantable IOL which offers multifocal vision.
| Study group | Role | What they receive |
|---|---|---|
| SAV multifocal IOL | Other | Subjects who have cataract surgery with SAV multifocal IOL Receives: Device: SAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected distant visual acuity
Visual acuity at distance with bare eyes
Measured: 3 months
Uncorrected near visual acuity
Visual acuity at near with bare eyes
Measured: 3 months
Secondary outcomes (2)
Contrast sensitivity
Ability to recognize letter or figure at different contrast environment
Measured: 3 months
Quality of Vision
Degree of various symptom associated with vision
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start11 Feb 2020
- Primary completion22 Jan 2021 (estimated)
- Study completion22 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tae-young chung, Samsung Medical Center
- Investigators
- Tae-Young Chung, PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391972
- Sponsor's protocol ID
- 2019-12-019
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Extended-depth-of-focus Intraocualr Lens (SAV) Implantation
- ClinicalTrials.gov ID
- NCT04391972
- Acronym / sponsor ID
- 2019-12-019
- Conditions
- Presbyopia
- Keywords
- depth and focus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 22 Jan 2021 (estimated)
- Study completion
- 22 Jan 2021 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAV multifocal IOL | Other | Device: SAVSubjects who have cataract surgery with SAV multifocal IOL |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAVSAV multifocal intraocular lens is a implantable IOL which offers multifocal vision. | Device | SAV multifocal IOL |
Primary outcome
Uncorrected distant visual acuity
Time frame: 3 months
Visual acuity at distance with bare eyes
Uncorrected near visual acuity
Time frame: 3 months
Visual acuity at near with bare eyes
2 secondary outcomes
Contrast sensitivity
Time frame: 3 months
Quality of Vision
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Young Chung, PhD study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAV in people with Presbyopia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae-Young Chung, PhD (82-2-3410-3548, taeyoung15.chung@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected distant visual acuity (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.