Magnetic Correction of Eye Lid Paralysis
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|ClinicalTrials.gov Identifier: NCT02988856|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2016
Last Update Posted : October 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Blepharoptosis Lagophthalmos Facial Paralysis||Device: Magnetic lid system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-surgical Correction of Eye Lid Paralysis With External Magnet Systems|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: Magnetic lid system
All participants will trial a commercially available device and an experimental magnetic device.
Device: Magnetic lid system
Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.
Other Name: Magnetic Levator and Magnetic Orbicularis
- Rating Scale of Skin Integrity [ Time Frame: 2 months ]Ratings at the beginning and end of treatment will be analyzed for differences.
- National Eye Institute rating scale [ Time Frame: 2 months ]Corneal staining scale
- Visual acuity [ Time Frame: 2 months ]Early treatment of diabetic retinopathy study letters on a standard 20 foot visual acuity chart
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988856
|United States, Massachusetts|
|Ophthalmology of Clinical Research Office, Mass Eye and Ear|
|Boston, Massachusetts, United States, 021141|
|Principal Investigator:||Kevin E Houston, OD||Massachusetts Eye and Ear|