CataractNCT02939001
Evaluating the Effect of Laser Vision Surgery, Phakic Intraocular Lens Implantation, Cataract Surgery, and Pupil Dilation on the Iris Recognition Scanner Function of Smartphone
A study testing iris recognition scanner in people with Cataract and Myopia, run by Yonsei University at 1 site in South Korea.
Trial summary
This study included patients who visit for refractive surgery (photorefractive keratectomy, photorefractive keratectomy with with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex), and cataract… Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract, Myopia, Myopic Astigmatism
- What is being tested?
- iris recognition scanner
- 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
- 3 Oct 2016to 24 Mar 2017
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who visit for refractive surgery (photorefractive keratectomy, photorefractive keratectomy with with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction)
- phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex)
- cataract surgery.
- age of 20~90
Who cannot join
- history of previous ocular or intraocular surgery
- glaucoma or ocular hypertension, ocular infection, non-dry eye ocular inflammation, ocular allergy, autoimmune disease
- history of iris damage during ocular surgery or previous trauma
- wearing contact lenses during the study period
- presence of current punctal occlusion
- pregnancy, lactating women, and children
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Seoul, 03722
About this study
This study included patients who visit for refractive surgery (photorefractive keratectomy, photorefractive keratectomy with with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex), and cataract surgery. Patients will be examined whether iris recognition scanner of smartphone works before and after surgery. In addition, before and after pupil dilation (5mm, 6mm, 7mm, 8mm), patients will be examined whether iris recognition scanner of smartphone works well.
- Conditions
- Cataract, Myopia, Myopic Astigmatism
- Being tested
- iris recognition scanner
- Medical subject headings
- Cataract, Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iris recognition scannerDevice
Also called Galaxy Note 7 (Smartphone)
| Study group | Role | What they receive |
|---|---|---|
| Ophthalmic surgery group | Experimental | Ophthalmic surgery group (refractive surgery, phakic Intraocular Lens implantation, and cataract surgery) Receives: Device: iris recognition scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
capability of iris recognition scanner
Patients will be examined whether iris recognition scanner of smartphone works 1 day before refractive surgery (photorefractive keratectomy, photorefractive keratectomy with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex), and cataract surgery.
Measured: 1 day before the surgery
capability of iris recognition scanner
Patients will be examined whether iris recognition scanner of smartphone works 1 week after refractive surgery (photorefractive keratectomy, photorefractive keratectomy with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex), and cataract surgery.
Measured: 1 week after the surgery
Secondary outcomes (2)
pupil dilation
Patients will be examined whether iris recognition scanner of smartphone works well 1 day before pupil dilation.
Measured: 1 day before pupil dilation
pupil dilation
Patients will be examined whether iris recognition scanner of smartphone works well 1 week after before pupil dilation.
Measured: 1 week after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start3 Oct 2016
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939001
- Sponsor's protocol ID
- 1-2016-0049
- Status last verified
- Jul 2018
- First submitted
- 18 Oct 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Laser Vision Surgery, Phakic Intraocular Lens Implantation, Cataract Surgery, and Pupil Dilation on the Iris Recognition Scanner Function of Smartphone
- ClinicalTrials.gov ID
- NCT02939001
- Acronym / sponsor ID
- 1-2016-0049
- Conditions
- Cataract, Myopia, Myopic Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 19 Oct 2016 (estimated)
- 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.
This study included patients who visit for refractive surgery (photorefractive keratectomy, photorefractive keratectomy with with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex), and cataract surgery. Patients will be examined whether iris recognition scanner of smartphone works before and after surgery. In addition, before and after pupil dilation (5mm, 6mm, 7mm, 8mm), patients will be examined whether iris recognition scanner of smartphone works well.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ophthalmic surgery group | Experimental | Device: iris recognition scannerOphthalmic surgery group (refractive surgery, phakic Intraocular Lens implantation, and cataract surgery) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who visit for refractive surgery (photorefractive keratectomy, photorefractive keratectomy with with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction)
- phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex)
- cataract surgery.
- age of 20~90
Key exclusion criteria (6 listed)
- history of previous ocular or intraocular surgery
- glaucoma or ocular hypertension, ocular infection, non-dry eye ocular inflammation, ocular allergy, autoimmune disease
- history of iris damage during ocular surgery or previous trauma
- wearing contact lenses during the study period
- presence of current punctal occlusion
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 |
|---|---|---|
| iris recognition scannerAlso: Galaxy Note 7 (Smartphone) | Device | Ophthalmic surgery group |
Primary outcome
capability of iris recognition scanner
Time frame: 1 day before the surgery
Patients will be examined whether iris recognition scanner of smartphone works 1 day before refractive surgery (photorefractive keratectomy, photorefractive keratectomy with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex), and cataract surgery.
capability of iris recognition scanner
Time frame: 1 week after the surgery
Patients will be examined whether iris recognition scanner of smartphone works 1 week after refractive surgery (photorefractive keratectomy, photorefractive keratectomy with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex), and cataract surgery.
2 secondary outcomes
pupil dilation
Time frame: 1 day before pupil dilation
pupil dilation
Time frame: 1 week after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iris recognition scanner in people with Cataract and Myopia, run by Yonsei University 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 4 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: finished, as of the sponsor's last update on 18 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
capability of iris recognition scanner (time frame: 1 day before the surgery). 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 Jul 2018.