Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

NCT04678115 | Completed Results DMC FDA Device

• 2 other identifiers: 2019P003055R01EY029437
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Interpalpebral Fissure (IPF) During Spontaneous Blink

  The primary outcome was objective measurement of the IPF midpoint height during maximum closing in five spontaneous blinks, captured with a Nikon mirrorless SLR video recording system (Z7II; Nikon USA, Melville, NY, USA), with a visible light source mounted just above the lens, measured manually with ImageJ (National Institutes of Health, Bethesda, MD, USA). Spontaneous blinks are normally incomplete, a behavior that is dependent upon age, gender, task, and environmental demands. Maximum closing was defined as the three points at the base of the blink. Participants were instructed to look at the camera lens and try to relax and behave normally. Recording was stopped after 1 minute or after five spontaneous blinks, whichever came first. Recording always occurred in the same windowless clinical research room with consistent lighting, temperature, humidity, and air flow. The IPF midpoint height during maximum closing in five spontaneous blinks is averaged and reported below.

  2 weeks

Secondary Outcomes (3)

• Interpalpebral Fissure During Resting Open

  2 weeks

• Proportion of Non-closure During Volitional Blinks

  2 weeks

• Proportion of Subjects Selecting Each Device

  6 weeks

Study Arms (2)

MLP first, KTFS second

EXPERIMENTAL

Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.

Device: Magnetic Levator Prosthesis (MLP); Device: Kinesiotape Frontalis Sling (KTFS)

KTFS first, MLP second

EXPERIMENTAL

Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.

Device: Magnetic Levator Prosthesis (MLP); Device: Kinesiotape Frontalis Sling (KTFS)

Interventions

Magnetic Levator Prosthesis (MLP) DEVICE

Neodymium magnet embedded in a glasses frame and a polymer embedded (PDMS) micro-magnet array fitted externally to the upper lid with IV 3000 securement film. The IV 3000 is FDA approved for extended wear on the skin.

KTFS first, MLP second; MLP first, KTFS second

Kinesiotape Frontalis Sling (KTFS) DEVICE

Kineso Tape is FDA registered as a 510K exempt class 1 device, typically used by physical and occupational therapist to support muscular healing and movement. It is sometimes used on the face in cases of facial palsy or on the eye lid to support the lid in cases of severe blepharoptosis. In such cases it may be attached near the lid margin above the lashes extending up to the forehead skin overlying the frontalis muscle. Alternatively it may be a very short piece attached only along the lid skin. The tape is easily removed.

KTFS first, MLP second; MLP first, KTFS second

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

Location

Related Publications (8)

• 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.

  PMID: 25674358 BACKGROUND

• 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.

  PMID: 29367892 BACKGROUND

• 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.

  PMID: 36269183 BACKGROUND

• 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.

  PMID: 37566397 BACKGROUND

• 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.

  PMID: 38038607 BACKGROUND

• 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.

  PMID: 34123530 BACKGROUND

• 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.

  PMID: 8565190 BACKGROUND

• 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.

  PMID: 39932468 RESULT

MeSH Terms

Conditions

Blepharoptosis; Myasthenia Gravis; Stroke; Brain Injuries, Traumatic; Ophthalmoplegia, Chronic Progressive External

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Mitochondrial Myopathies; Muscular Diseases; Musculoskeletal Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Kevin Houston
• Organization: VA Central Western Massachusetts

kevin.houston2@va.gov

781-588-7674

Study Officials

• Kevin Houston, OD MSc

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 21, 2020
• Study Start: June 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 22, 2025
• Results First Posted: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)