Lower Eyelid EntropionNCT00842764
Minimally Invasive Holmium:YAG Laser Blepharoplasty
A study testing Holmium: YAG laser in people with Lower Eyelid Entropion, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this research study is to is to evaluate the safety and effectiveness of the FDA approved Holmium:YAG laser for reducing lower eyelid bags. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Eyelid Entropion
- What is being tested?
- Holmium: YAG laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male/female 30 years and older
- have pronounced lower eyelid fat pads.
Who cannot join
- based on medical problems.
- Previous surgery or trauma to lower eyelid or orbit.
- pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to is to evaluate the safety and effectiveness of the FDA approved Holmium:YAG laser for reducing lower eyelid bags.
Read the detailed description
The researchers are interested in learning if the more precise Holmium:YAG laser can effectively tighten the orbital septum, a barrier of the orbit which holds fat in the bony orbit, while resulting in less unintentional surrounding damage and side effects.
- Conditions
- Lower Eyelid Entropion
- Being tested
- Holmium: YAG laser
- Keywords
- eyelid fat pads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium: YAG laserProcedure or surgery
Minimally Invasive Holmium:YAG laser Blepharoplasty
| Study group | Role | What they receive |
|---|---|---|
| Holmium: YAG laser | Experimental | Subjects will go under minimally invasive Holmium: YAG laser blepharoplasty Receives: Procedure: Holmium: YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Eyelid Bags.
Preoperative and postoperative (postoperative visits were at day 1, 1 week, 1 month, and 2 months) .photographs were evaluated by 6 surgeons on a 5-point Likert scale which 1 indicates worsening, 2 means unchanged, 3 is mild improvement, 4 is moderate improvement, and 5 indicates complete correction.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Eyelid EntropionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Brian J Wong, M.D,PhD, Principal investigator, Otolaryngology, UCIMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842764
- Sponsor's protocol ID
- 20086593
- Status last verified
- Oct 2022
- First submitted
- 11 Feb 2009
- Last updated
- 1 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Holmium:YAG Laser Blepharoplasty
- ClinicalTrials.gov ID
- NCT00842764
- Acronym / sponsor ID
- 20086593
- Conditions
- Lower Eyelid Entropion
- Keywords
- eyelid fat pads
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Jan 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Posted 4 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to is to evaluate the safety and effectiveness of the FDA approved Holmium:YAG laser for reducing lower eyelid bags.
Detailed description
The researchers are interested in learning if the more precise Holmium:YAG laser can effectively tighten the orbital septum, a barrier of the orbit which holds fat in the bony orbit, while resulting in less unintentional surrounding damage and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Holmium: YAG laser | Experimental | Procedure: Holmium: YAG laserSubjects will go under minimally invasive Holmium: YAG laser blepharoplasty |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male/female 30 years and older
- have pronounced lower eyelid fat pads.
Key exclusion criteria (3 listed)
- based on medical problems.
- Previous surgery or trauma to lower eyelid or orbit.
- pregnant or lactating.
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 |
|---|---|---|
| Holmium: YAG laserMinimally Invasive Holmium:YAG laser Blepharoplasty | Procedure or surgery | Holmium: YAG laser |
Primary outcome
Change in Lower Eyelid Bags.
Time frame: 2 months
Preoperative and postoperative (postoperative visits were at day 1, 1 week, 1 month, and 2 months) .photographs were evaluated by 6 surgeons on a 5-point Likert scale which 1 indicates worsening, 2 means unchanged, 3 is mild improvement, 4 is moderate improvement, and 5 indicates complete correction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Brian J Wong, M.D,PhD principal investigator
Otolaryngology, UCIMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holmium: YAG laser in people with Lower Eyelid Entropion, run by University of California, Irvine at 1 site in United States.
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 2 inclusion and 3 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 1 Nov 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Lower Eyelid Bags. (time frame: 2 months). 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 1 Nov 2022.