Cataract PatientsNCT02567565
Evaluation of Tear Film Lipid Layer Thickness Change After Cataract Surgery
An observational study of Cataract Patients, run by Yonsei University at 1 site in South Korea.
Trial summary
This study will compare cataract patients before and after phacoemulsification. Evaluations will be performed before and 1 and 3 months following cataract surgery, including measurement of tear film lipid layer thickness, tear film break up time, Schirmer test, corneal and conjunctival fluorescein staining… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cataract Patients
- What is being tested?
- LipiView
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Oct 2015
- How long will I take part?
- 3 Months
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cataract patients with lens opacities classification higher than grade III
Who may be able to join
- cataract patients with lens opacities classification higher than grade III and desire to be spectacle independence for distance and near vision
Who cannot join
- previous ocular surgery or trauma and the presence of corneal opacities, fundus abnormalities, glaucoma, uveitis, amblyopia, systemic disease, and posterior capsule rupture during cataract surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Yonsei University College of Medicine
Seoul, Seoul, 03722
About this study
This study will compare cataract patients before and after phacoemulsification. Evaluations will be performed before and 1 and 3 months following cataract surgery, including measurement of tear film lipid layer thickness, tear film break up time, Schirmer test, corneal and conjunctival fluorescein staining, examination of lid margins and meibomian glands, and the Ocular Surface Disease Index.
- Conditions
- Cataract Patients
- Being tested
- LipiView
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipiViewOther
tear film lipid layer thickness measured by LipiView interferometer (TearScience Inc, Morrisville, NC)
| Study group | Role | What they receive |
|---|---|---|
| cataract patients | cataract patients undergoing phacoemulsification Receives: Other: LipiView |
What is being measured
The primary outcome is the main question the study is designed to answer.
tear film lipid layer thickness
tear film lipid layer thickness measured by LipiView interferometer
Measured: 3-month after phacoemulsification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract PatientsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tae-im Kim, MD, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567565
- Sponsor's protocol ID
- 4-2015-0225
- Status last verified
- Oct 2015
- First submitted
- 1 Oct 2015
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tear Film Lipid Layer Thickness Change After Cataract Surgery
- ClinicalTrials.gov ID
- NCT02567565
- Acronym / sponsor ID
- 4-2015-0225
- Conditions
- Cataract Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Oct 2015 (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 will compare cataract patients before and after phacoemulsification. Evaluations will be performed before and 1 and 3 months following cataract surgery, including measurement of tear film lipid layer thickness, tear film break up time, Schirmer test, corneal and conjunctival fluorescein staining, examination of lid margins and meibomian glands, and the Ocular Surface Disease Index.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cataract patients | – | Other: LipiViewcataract patients undergoing phacoemulsification |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cataract patients with lens opacities classification higher than grade III
Key inclusion criteria (1 listed)
- cataract patients with lens opacities classification higher than grade III and desire to be spectacle independence for distance and near vision
Key exclusion criteria (1 listed)
- previous ocular surgery or trauma and the presence of corneal opacities, fundus abnormalities, glaucoma, uveitis, amblyopia, systemic disease, and posterior capsule rupture during cataract surgery
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 |
|---|---|---|
| LipiViewtear film lipid layer thickness measured by LipiView interferometer (TearScience Inc, Morrisville, NC) | Other | cataract patients |
Primary outcome
tear film lipid layer thickness
Time frame: 3-month after phacoemulsification
tear film lipid layer thickness measured by LipiView interferometer
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 5 Oct 2015.
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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-im Kim, MD, Ph.D principal investigator
Severance Hospital
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 Patients, 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 5 Oct 2015. 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?
tear film lipid layer thickness (time frame: 3-month after phacoemulsification). 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 5 Oct 2015.