← Back to Search

Non-Surgical Treatments for Drooping Eyelid

N/A

Waitlist Available

Led By Kevin Houston, OD MSc

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of ptosis for at least one eye which occludes the visual axis in the resting position (without frontalis drive, lifting with forehead muscles)

Must not have

History of hyperthyroidism or thyroid eye disease (ie, exophthalmos, upper eyelid retraction, diplopia secondary to extraocular muscle involvement). Hypothyroidism that is controlled on medication is allowed

Previous ptosis surgery less than 3 months prior to Visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two devices to see which is better at improving eye lid opening for patients with severe Blepharoptosis.

Who is the study for?

This trial is for individuals with severe Blepharoptosis, where one eyelid droops enough to block vision. Participants must have moderate or better cognitive function (score ≥18 on MMSE). Excluded are those with weak eye muscles, recent ptosis surgery, severe cognitive issues, mechanical causes of ptosis like tumors or scarring, and certain medical conditions.

What is being tested?

The study compares two non-surgical devices: Magnetic Levator Prosthesis (MLP) and Kinesiotape Frontalis Sling (KTFS), both designed to help lift the eyelids in patients who can't fully open them due to various underlying conditions.

What are the potential side effects?

Potential side effects may include skin irritation from device contact, discomfort during use, possible allergic reactions to materials in the devices, and fatigue of forehead muscles from compensatory lifting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a droopy eyelid that covers my eye even when I'm not raising my eyebrows.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of thyroid issues but my hypothyroidism is under control with medication.

Select...

I had surgery for droopy eyelids less than 3 months ago.

Select...

I have muscle weakness around my eye on the same side as my droopy eyelid.

Select...

My eyelid position is affected by scarring.

Select...

I have a corneal ulcer.

Select...

I am under 5 years old.

Select...

My eyelids do not droop over my eyes blocking my vision.

Select...

I have a droopy eyelid due to a tumor, scarring, or eye sinking.

Select...

I have reduced sensation in my cornea.

Select...

I haven't had Botox or similar injections near my eye with drooping in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after)

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after) for reporting.