N/A
N=16
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Blepharoptosis · Ptosis, Eyelid · Myasthenia Gravis · Stroke · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT04678115 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Interpalpebral Fissure (IPF) During Spontaneous Blink — 2.4; 4.1; 1.1 millimeters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnetic Levator Prosthesis (MLP) (Device); Kinesiotape Frontalis Sling (KTFS) (Device)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interpalpebral Fissure (IPF) During Spontaneous Blink |
2.4; 4.1; 1.1 | <0.001 sig |
| SECONDARY Interpalpebral Fissure During Resting Open |
6.8; 7.0; 3.9 | 0.001 sig |
| SECONDARY Proportion of Non-closure During Volitional Blinks |
0.067; 0.356; 0.022 | 0.001 sig |
| SECONDARY Proportion of Subjects Selecting Each Device |
7; 6; 2 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04678115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.