Stroke Clinical Trial
Official title:
A Randomized Cross-Over Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Verified date | May 2024 |
Source | Massachusetts Eye and Ear Infirmary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts Eye and Ear | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts Eye and Ear Infirmary | National Eye Institute (NEI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between MLP and KTFS in the change in interpalpebral fissure during opening and spontaneous blinking | Measurements of the interpalpebral fissure will be taken from video recordings of eye lid opening and closing when using each of the devices | Evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after) | |
Secondary | Difference between MLP and KTFS in the changes in interpalpebral fissure during volitional blinking | Measurements of the interpalpebral fissure will be taken from video recordings of volitional eye lid closing when using each of the devices | Evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after) | |
Secondary | Proportion of subjects selecting each device | Proportion of subjects selecting either the MLP, the KTFS or neither | At the end of the one-week period of home use of the second device |
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