Non-Surgical Treatments for Drooping Eyelid

Overseen By Kevin Houston, OD MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: Periocular neurotoxins

Disqualifiers: Corneal ulcer, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial will evaluate two non-surgical devices designed to improve eye lid opening for patients with severe Blepharoptosis (incomplete opening of the eyelids).

Research Team

Kevin Houston, OD MSc

Principal Investigator

Massachusetts Eye and Ear

Eligibility Criteria

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.

Inclusion Criteria

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

You need to be able to answer most questions correctly on a test called the Mini-Mental State Exam.

Exclusion Criteria

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

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Crossover Treatment

Participants receive training and use each device at home for one week with daily follow-up by video calls

2 weeks

2 visits (in-person), daily follow-up (virtual)

Washout Period

A washout period between the use of the two devices

1 week

Follow-up

Participants complete a questionnaire comparing the two devices and select their preferred device

1 week

Treatment Details

Interventions

• Kinesiotape Frontalis Sling (KTFS)
• Magnetic Levator Prosthesis (MLP)

Trial Overview 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.

Participant Groups

Group I: MLP first, KTFS second Experimental Treatment 2 Interventions

Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.

Group II: KTFS first, MLP second Experimental Treatment 2 Interventions

Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+