Clinical Trial Comparing Two Non-Surgical Treatments for Severe

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

Two non-surgical devices for patients with Blepharoptosis will be evaluated. The Magnetic Levator Prosthesis (MLP), is an external device that makes use of a newer class of permanent magnets (made of alloys of neodymium (Nd), iron (Fe) and boron (B)) to restore eyelid movement. The Kinesiotape Frontalis Sling (KTFS), involves the use of tape to help facilitate levator muscle contraction to open the eyelid. Video recordings of spontaneous and volitional blinks will be used to evaluate the effects of each device on eyelid reanimation. The clinical trial will employ a crossover design in which participants will try each device at home in counterbalanced order with a washout period between. In each period of the crossover, participants will receive training (during study visits at Massachusetts Eye and Ear) in how to apply the device and will then try the device at home for one week with daily follow up by video calls. At the end of the one-week period of home use there will be a study visit at Massachusetts Eye and Ear when the device will be returned and additional video recordings of eye blinks will be made. At the end of the crossover period, participants will be asked to complete a questionnaire comparing the two devices and to select their preferred device. If considered clinically appropriate, participants may be invited to continue using the preferred device for an additional two months with weekly follow ups to provide information about longer-term use of the intervention. Participants who are still using one of the devices at the end of the two months will be returned to clinical care and receive a study follow up (telephone call) after another 6 and 12 months. ;

Study Design

Related Conditions & MeSH terms

Blepharoptosis
Brain Injuries
Brain Injuries, Traumatic
Chronic Progressive External Ophthalmoplegia
Myasthenia Gravis
Ophthalmoplegia
Ptosis, Eyelid
Stroke
Traumatic Brain Injury

Clinical Trial Details

NCT number	NCT04678115
Study type	Interventional
Source	Massachusetts Eye and Ear Infirmary
Contact	Kevin Houston, OD MSc
Phone	617-573-4177
Email	Kevin_Houston@meei.harvard.edu
Status	Recruiting
Phase	N/A
Start date	June 1, 2021
Completion date	July 1, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms