CataractNCT02194543
High-Definition 3D Visualization System for Ophthalmic Surgery
An observational study of Cataract, run by Yonsei University at 1 site in South Korea.
Trial summary
To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract surgery Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Jul 2014
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cataract
Who may be able to join
- The patients are scheduled to cataract surgery on both eyes.
Who cannot join
- The patients who have other complicating ophthalmic diseases or previous history of ophthalmic surgeries were excluded
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract surgery
- Conditions
- Cataract
- Keywords
- Cataract, HD 3D, Microscope
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HD 3D | The patients received surgeries with HD 3D on their left eyes. | |
| Conventional | The patients received surgeries with conventional method on the other eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the best corrected visual acuity
operation time, total phacoemulsification time, and postoperative visual outcome
Measured: 1 month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 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
- NCT02194543
- Sponsor's protocol ID
- 1-2014-0002
- Status last verified
- Jul 2014
- First submitted
- 16 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Definition 3D Visualization System for Ophthalmic Surgery
- ClinicalTrials.gov ID
- NCT02194543
- Acronym / sponsor ID
- 1-2014-0002
- Conditions
- Cataract
- Keywords
- Cataract, HD 3D, Microscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Jul 2014 (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.
To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract surgery
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD 3D | – | –The patients received surgeries with HD 3D on their left eyes. |
| Conventional | – | –The patients received surgeries with conventional method on the other eye. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cataract
Key inclusion criteria (1 listed)
- The patients are scheduled to cataract surgery on both eyes.
Key exclusion criteria (1 listed)
- The patients who have other complicating ophthalmic diseases or previous history of ophthalmic surgeries were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the best corrected visual acuity
Time frame: 1 month after the operation
operation time, total phacoemulsification time, and postoperative visual outcome
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 2014.
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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.
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?
An observational study of Cataract, 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 1 inclusion and 1 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 2014. 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?
the best corrected visual acuity (time frame: 1 month after the operation). 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 2014.