Health TrialsbyHealthPanel

Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion

ConditionChalazion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLumenis Be Ltd.

About this trial

To study the effectiveness and safety of IPL treatment for Chalazion

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is able to read, understand, and sign an Informed Consent Form (ICF)

18 years of age or older

Clinical diagnosis of chalazion in the inflammatory stage

Subject is willing to comply with all study procedures-

Disqualifiers

Concurrent eyelid infection

Chalazion with atypical features, which to the opinion of the study investigator is inadequate for a study

Recurring Chalazion

Floppy eyelid syndrome

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sham IPL

    Device

    Three sham IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment

  • Active IPL

    Device

    Three active IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: study armExperimental treatment 1 intervention
Group B: Control armSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group

the proportion of subjects with reduction of at lease 80% in lesion size at the follow up visit

Time frame
4 weeks after the last treatment

Secondary outcomes

1

Percentage change from baseline in lesion size in both groups

measuring the lesion size using a millimeter caliper

Time frame
4 weeks after the last treatment
2

Time to resolution which is defined as a reduction of at least 80% in lesion size in both groups

measuring the time that takes for a reduction of at least 80% in lesion size

Time frame
4 weeks after last treatment

Other outcomes

1

modified Meibomian Gland Score

15 Meibomian glands along the lower lid (5 nasal + 5 central + 5 temporal) will be gently expressed with the dedicated expression forceps. Each gland will be scored 0 to 3, as follows: 0 = clear liquid meibum; 1 = cloudy liquid meibum; 2 = inspissated meibum; 3 = blocked). The modified Meibomian Gland score will be evaluated as the sum of scores for these 15 glands. Hence, the minimal value is 0 (all 15 glands express a clear liquid meibum), and the maximal value is 45 (all 15 glands are blocked). A decrease in the modified Meibomian Gland Score means that the functionality of Meibomian glands improved, and that the condition of the patient improved.

Time frame
4 weeks after the last treatment
2

Teat Breakup time

Time between full blink and first appearance of a break in a fluorescein-stained eye

Time frame
4 weeks after the last treatment
3

BCVA

Best-corrected visual acuity, using an ETDRS chart (20/20, 20/25, 20/32,20/40,20/50,20/63, 20/80, 20/100, 20/200, 20/400, where 20/20 is considered perfect vision and 20/400 is considered legal blindness)

Time frame
4 weeks after the last treatment
4

Adverse events

Incidence and type of adverse events

Time frame
up to 7 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lumenis Be Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: