ChalazionNCT05070611
Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia
A study testing IPL-MGX in people with Chalazion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery. Read more about this study
- Who is it for?
- Ages 24 to 74 years
- Conditions the study is for
- Chalazion
- What is being tested?
- IPL-MGX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Nov 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 24 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients had chronic unilateral recurrent chalazia that failed to resolve after conservative treatment that included warm compresses and antibiotic and steroid ophthalmic ointments.
Who cannot join
- (1) any intraocular inflammation, ocular infection, allergy, ocular surgery, or ocular trauma in the past 6 months; (2) any eyelid diseases or structural abnormality; (3) any systematic diseases may lead to dry eye or MGD; (4) skin cancer or pigmented lesion in the treatment zone.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University Hospital
Hangzhou
zhu y rui, 15868805518, zhuyirui001@126.com
About this study
The purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery.
Read the detailed description
We hypothesized that IPL application on the skin adjacent to eyelids after chalazion surgery will result in better meibomian gland function and lower recurrence. To date, it has not been previously reported the outcomes of the use of this technology for the management of chalazions recurrence. The purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery.
- Conditions
- Chalazion
- Being tested
- IPL-MGX
- Keywords
- Chalazion, IPL, Meibomian gland function
- Medical subject headings
- Chalazion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPL-MGXDevice
One week after lesion incision, the E-Eye machine (E-SWIN company, France) IPL treatment was administered to the skin area below the lower eyelid.13 Before treatment, the eyes were protected with opaque goggles and ultrasound gel was applied on the patient's face from tragus to tragus including the nose to conduct the light.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent chalazia with IPL-MGX | Experimental | The patients whose lesions had failed to respond to warm compresses and antibiotic and steroid treatment underwent incision and curettage. One week after lesion incision, the E-Eye machine (E-SWIN company, France) IPL treatment was administered to the skin area below the lower eyelid. After removal of the ultrasound gel, meibomian gland expression (MGX) was performed with forceps-shaped meibomian gland compressor. Receives: Device: IPL-MGX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of chalazia
The recurrence rate of the recurrent chalazia
Measured: an average of 1 year
Secondary outcomes (3)
NITBUT
non-invasive tear film breakup time
Measured: an average of 1 year
meibomian expressibility and quality
The expressibility and quality score of the meibum
Measured: an average of 1 year
TMH
tear meniscus height
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start1 Jul 2020
- Primary completion1 Aug 2020
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChalazionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lin lin, Study chair, Second Affiliated Hospital of Zhejiang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070611
- Sponsor's protocol ID
- 2021-0562
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia
- ClinicalTrials.gov ID
- NCT05070611
- Acronym / sponsor ID
- 2021-0562
- Conditions
- Chalazion
- Keywords
- Chalazion, IPL, Meibomian gland function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 7 Oct 2021 (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.
The purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery.
Detailed description
We hypothesized that IPL application on the skin adjacent to eyelids after chalazion surgery will result in better meibomian gland function and lower recurrence. To date, it has not been previously reported the outcomes of the use of this technology for the management of chalazions recurrence. The purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent chalazia with IPL-MGX | Experimental | Device: IPL-MGXThe patients whose lesions had failed to respond to warm compresses and antibiotic and steroid treatment underwent incision and curettage. One week after lesion incision, the E-Eye machine (E-SWIN company, France) IPL treatment was administered to the skin area below the lower eyelid. After removal of the ultrasound gel, meibomian gland expression (MGX) was performed with forceps-shaped meibomian gland compressor. |
Who may qualify
- Ages
- 24 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients had chronic unilateral recurrent chalazia that failed to resolve after conservative treatment that included warm compresses and antibiotic and steroid ophthalmic ointments.
Key exclusion criteria (1 listed)
- (1) any intraocular inflammation, ocular infection, allergy, ocular surgery, or ocular trauma in the past 6 months; (2) any eyelid diseases or structural abnormality; (3) any systematic diseases may lead to dry eye or MGD; (4) skin cancer or pigmented lesion in the treatment zone.
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 |
|---|---|---|
| IPL-MGXOne week after lesion incision, the E-Eye machine (E-SWIN company, France) IPL treatment was administered to the skin area below the lower eyelid.13 Before treatment, the eyes were protected with opaque goggles and ultrasound gel was applied on the patient's face from tragus to tragus including the nose to conduct the light. | Device | Recurrent chalazia with IPL-MGX |
Primary outcome
Recurrence rate of chalazia
Time frame: an average of 1 year
The recurrence rate of the recurrent chalazia
3 secondary outcomes
NITBUT
Time frame: an average of 1 year
meibomian expressibility and quality
Time frame: an average of 1 year
TMH
Time frame: an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
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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.
lin lin study chair
Second Affiliated Hospital of Zhejiang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPL-MGX in people with Chalazion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 7 Oct 2021. 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 China. 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 jin x ming (13989455778, 18344980413@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of chalazia (time frame: an average of 1 year). 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 7 Oct 2021.