Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

Completed · Not applicable

Conditions studied: Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis, Stroke, Traumatic Brain Injury, Chronic Progressive External Ophthalmoplegia

In brief

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).

Key facts

Study ID

NCT04678115

Run by

Massachusetts Eye and Ear Infirmary

People needed

16

Starts

2021-06-01

Expected to finish

2024-12-31

Last updated by the study team

2025-04-22

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of ptosis for at least one eye which occludes the visual axis in the resting position (without frontalis drive, lifting with forehead muscles)
• Moderate cognitive function or better defined as greater than or equal to 18 out of 30 on a pre-screening of the Mini-Mental State Exam (MMSE)

You may not qualify if…

• Absence of ptosis which occludes the visual axis
• Presence of a corneal ulcer of any size
• Age less than 5 years
• Severe Cognitive impairment defined as MMSE score less than 18, behaviors consistent with delirium (combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy.
• Presence of corneal hypoaesthesia;
• Orbicularis weakness on the side of the ptosis
• Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
• Previous ptosis surgery less than 3 months prior to Visit 1.
• Lid position affected by lid or conjunctival scarring.
• History of herpes keratitis.
• Periocular neurotoxin (eg, Botox, Xeomin, Dysport, Myobloc) injections on the side of the ptosis within 3 months prior to Visit 1 and during the study.
• 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

Where it is running

• Massachusetts Eye and Ear — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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