Status:
COMPLETED
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Blepharoptosis
Ptosis, Eyelid
Eligibility:
All Genders
5+ years
Phase:
NA
Brief Summary
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).
Detailed Description
Two non-surgical devices for patients with Blepharoptosis will be evaluated. The Magnetic Levator Prosthesis (MLP), is an external device that makes use of a newer class of permanent magnets (made of ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04678115
Start Date
June 1 2021
End Date
December 31 2024
Last Update
April 22 2025
Active Locations (1)
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1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114