Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis (NCT04678115) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
United States16 participantsStarted 2021-06-01
Plain-language 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).
Who can participate
Age range5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Interpalpebral Fissure (IPF) During Spontaneous Blink