Clinical trial · Interventional
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
A Randomized Cross-Over Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
NCT04678115CI-TRIAL-00088756completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blepharoptosis | — | UNRESOLVED | — |
| Chronic Progressive External Ophthalmoplegia | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Ptosis, Eyelid | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
| Traumatic Brain Injury | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Kinesiotape Frontalis Sling (KTFS) | Device | — | UNRESOLVED |
| Magnetic Levator Prosthesis (MLP) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MLP first, KTFS second
- description
- Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.
- interventionNames
- Device: Magnetic Levator Prosthesis (MLP)
- Device: Kinesiotape Frontalis Sling (KTFS)
- type
- EXPERIMENTAL
- label
- KTFS first, MLP second
- description
- Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.
- interventionNames
- Device: Magnetic Levator Prosthesis (MLP)
- Device: Kinesiotape Frontalis Sling (KTFS)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDHouston 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
- BACKGROUNDHouston 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
- BACKGROUNDHouston 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
- BACKGROUNDKurukuti 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
- BACKGROUNDTirandazi 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
- BACKGROUNDCheatham 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
- BACKGROUNDLemp 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