Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02988856
Other study ID # 15-027H
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2015
Est. completion date May 14, 2019

Study information

Verified date October 2020
Source Massachusetts Eye and Ear Infirmary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective 1: Determine the safety and feasibility of externally mounted magnets for extended management of chronic eyelid movement disorders by measuring visual acuity and corneal and skin integrity and comfort over 8 weeks of wear. Objective 2: Collect preliminary data on the relative efficacy of external magnetic devices by comparing them to externally mounted lid weights and ptosis crutches using rating scales and video analysis of blink biomechanics.


Description:

Two major types of eye lid movement disorders include lagophthalmos (incomplete closure of the eyelids) and blepharoptosis (incomplete opening of the eyelids). Both of these conditions occur because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. Generally paralysis of the eyelid or facial muscles is responsible for the abnormality (the eyelids can close but not open, or open but not close). An external device, if able to generate an appropriately balanced force, could restore eyelid movement by performing the paralyzed function; for example, a ptotic (droopy) eyelid could be opened, and the functioning eyelid closure muscle could overcome the device's force. In prior work the investigators established proof-of-concept data demonstrating safety and efficacy for temporary management of ptosis up to 2 hour per day for 2 weeks. Preliminary data suggest similar safety for lagophthalmos. This study will expand on this preliminary work to examine longer wear times, home use, and feasibility for a wider range of eye lid disorders.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date May 14, 2019
Est. primary completion date May 14, 2019
Accepts healthy volunteers No
Gender All
Age group 5 Years and older
Eligibility Inclusion Criteria: - Presence of an eyelid movement disorder for at least one eye, 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, age 5 or older. Exclusion Criteria: - Absence of an eyelid movement disorder or presence of a corneal ulcer. Those with a corneal ulcer are at risk for permanent loss of vision and should be managed with proven methods. Age less than 5, Severe Cognitive impairment defined as Mini-mental score <18, behaviors consistent with delirium (combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy. These individuals must be excluded since participation requires competent self-care, reliable responses and cooperation during fitting of the devices.

Study Design


Intervention

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.

Locations

Country Name City State
United States Ophthalmology of Clinical Research Office, Mass Eye and Ear Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Kevin Houston

Country where clinical trial is conducted

United States, 

References & Publications (1)

Singh NK, Paschalis EI, Tomasi M, Rizzo JF, Houston KE. The boston blink-netic project: preliminary outpatient feasibility results (abstract). Optom Vis Sci 2016;93: E-abstract 16118.

Outcome

Type Measure Description Time frame Safety issue
Primary Rating Scale of Skin Integrity Ratings at the beginning and end of treatment will be analyzed by calculating the mean and standard deviation of the skin erythema rating across all available time points. The outcome measure is the FDA scale, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry. Range is 0 to 7 with higher numbers being worse skin erythema. Baseline and up to 32 weeks
Secondary Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale Using the National Eye Institute Rating Scale (0 to 3 points with higher being more staining), cases where staining increased more than 2 points or if there was any ulceration, an adverse event was tabulated and summed for each participant over 1 up to 32 weeks of use, depending on how long the participant was followed. Baseline and up to 32 weeks
Secondary Change in Visual Acuity Visual acuity at 20ft before treatment and after 1 week or more. Difference between weekly acuity measures to baseline was calculated and averaged for each subject, and then a group mean and standard deviation calculated. Baseline and up to 32 weeks
See also
  Status Clinical Trial Phase
Completed NCT00864656 - Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine N/A
Recruiting NCT02959697 - Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair N/A
Recruiting NCT02501187 - Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair N/A
Completed NCT00793988 - Vibration-Assisted Anaesthesia Phase 4
Completed NCT02367677 - Digital Photographs to Evaluate Blepharoptosis N/A
Recruiting NCT01239498 - Saline Injection - Assisted Anesthesia in Eyelid Surgery Phase 4
Not yet recruiting NCT05358977 - Fibrin Sealant in Eyelid Surgery Phase 2/Phase 3
Completed NCT01848041 - Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis Phase 1/Phase 2
Completed NCT01350024 - Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid N/A
Completed NCT06047418 - Blepharoptosis in Indonesia: A 5-Year Multicenter Study on Characteristics and Surgical Evaluation
Active, not recruiting NCT03149367 - Surgical Management of Blepharoptosis N/A
Completed NCT03565887 - Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis Phase 3
Recruiting NCT01968174 - Astigmatic Changes Secondary to Eyelid Surgeries N/A
Completed NCT03536949 - Study of Safety of RVL-1201 in Treatment of Blepharoptosis Phase 3
Active, not recruiting NCT04678115 - Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis N/A
Not yet recruiting NCT04235803 - Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery N/A
Terminated NCT03239418 - NMES to Improve Eyelid Functions in Cranial Nerve (CN) III and VII Palsy N/A
Not yet recruiting NCT02638610 - Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries N/A
Enrolling by invitation NCT05945615 - Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis Phase 3
Recruiting NCT06292182 - Red Light Ptosis Proof-of-Concept N/A