Clinical trial NCT04678115: Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Official title: A Randomized Cross-Over Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blepharoptosis
Ptosis, Eyelid
Myasthenia Gravis
Stroke
Traumatic Brain Injury
Chronic Progressive External Ophthalmoplegia
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2020-12-21
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Interpalpebral Fissure (IPF) During Spontaneous Blink
timeFrame: 2 weeks
Secondary outcomes:
measure: Interpalpebral Fissure During Resting Open
timeFrame: 2 weeks
measure: Proportion of Non-closure During Volitional Blinks
timeFrame: 2 weeks
measure: Proportion of Subjects Selecting Each Device
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear
name: Kevin Houston, OD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Houston KE, Tomasi M, Yoon M, Paschalis EI. A Prototype External Magnetic Eyelid Device for Blepharoptosis. Transl Vis Sci Technol. 2014 Dec 17;3(6):9. doi: 10.1167/tvst.3.6.9. eCollection 2014 Oct.
citation: Houston KE, Tomasi M, Amaral C, Finch N, Yoon MK, Lee H, Paschalis EI. The Magnetic Levator Prosthesis for Temporary Management of Severe Blepharoptosis: Initial Safety and Efficacy. Transl Vis Sci Technol. 2018 Jan 19;7(1):7. doi: 10.1167/tvst.7.1.7. eCollection 2018 Jan.
citation: Houston KE, Paschalis EI. Feasibility of Magnetic Levator Prosthesis Frame Customization Using Craniofacial Scans and 3-D Printing. Transl Vis Sci Technol. 2022 Oct 3;11(10):34. doi: 10.1167/tvst.11.10.34.
citation: Kurukuti NM, Nadeau M, Paschalis EI, Houston KE. An Adjustable Magnetic Levator Prosthesis for Customizable Eyelid Re-Animation in Severe Blepharoptosis: Design and Proof-of-Concept. Transl Vis Sci Technol. 2023 Aug 1;12(8):11. doi: 10.1167/tvst.12.8.11.
citation: Tirandazi P, Nadeau M, Woods RL, Paschalis EI, Houston KE. An Adjustable Magnetic Levator Prosthesis for Customizable Eyelid Reanimation in Severe Blepharoptosis II: Randomized Evaluation of Angular Translation. Transl Vis Sci Technol. 2023 Dec 1;12(12):1. doi: 10.1167/tvst.12.12.1.
citation: Cheatham SW, Baker RT, Abdenour TE. Kinesiology Tape: A Descriptive Survey of Healthcare Professionals in the United States. Int J Sports Phys Ther. 2021 Jun 1;16(3):778-796. doi: 10.26603/001c.22136.
citation: Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. No abstract available.
citation: Houston KE, Pundlik S, Shivshanker P, Bowers AR, LaRosa S, Robinson M, Chodosh J, Brandes L, Lee P, Paschalis EI. A Single-Center Sham and Active-Controlled Double-Blind Randomized Crossover Trial of the Magnetic Levator Prosthesis for Severe Blepharoptosis. Transl Vis Sci Technol. 2025 Feb 3;14(2):15. doi: 10.1167/tvst.14.2.15.