Non-Surgical Treatments for Drooping Eyelid
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two non-surgical devices for severe Blepharoptosis, a condition where the upper eyelid droops and blocks vision. The devices, Kinesiotape Frontalis Sling (KTFS) and Magnetic Levator Prosthesis (MLP), are being evaluated to determine which better opens the eyelids. Participants will use both devices in different sequences to compare their effectiveness. Suitable candidates for this trial have eyelids that droop enough to block vision without using forehead muscles to lift them. As an unphased trial, this study provides participants with the chance to explore innovative solutions for improving vision.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have had periocular neurotoxin injections (like Botox) on the side of the ptosis within 3 months before the study, you may not be eligible.
What prior data suggests that these non-surgical devices are safe for improving eyelid opening?
Research has shown that both the Kinesiotape Frontalis Sling (KTFS) and the Magnetic Levator Prosthesis (MLP) could help with drooping eyelids. Studies indicate that the KTFS significantly lifts the eyelid and is often used safely for severe cases.
Research has found the MLP safe and effective for short-term use, aiding eyelid movement. Most patients rated the MLP as very comfortable, with an average score of 9 out of 10. Overall, both treatments are generally well-tolerated, with no major safety issues reported.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for drooping eyelid because they offer non-surgical alternatives to traditional procedures like blepharoplasty. The Kinesiotape Frontalis Sling (KTFS) uses a specialized taping technique to lift the eyelid, which is less invasive and can be easily adjusted by users. Meanwhile, the Magnetic Levator Prosthesis (MLP) uses magnets to elevate the eyelid, providing a novel mechanism that doesn't require surgery or direct contact with the skin. These methods not only reduce the risks associated with surgery but also offer more customizable and reversible options for patients.
What evidence suggests that these devices are effective for severe Blepharoptosis?
This trial will compare two non-surgical treatments for severe drooping eyelids, known as blepharoptosis: the Kinesiotape Frontalis Sling (KTFS) and the Magnetic Levator Prosthesis (MLP). Research shows both treatments hold promise. Studies on the MLP have demonstrated significant improvement in eyelid opening, with 88% of participants achieving successful results. The KTFS is also considered safe and effective, noticeably enhancing eyelid movement. One study found the MLP outperformed kinesiology tape for severe drooping, suggesting it might be a better choice for some individuals. Participants in this trial will receive both treatments in a crossover design, offering non-surgical options to improve eyelid function for those with this condition.26789
Who Is on the Research Team?
Kevin Houston, OD MSc
Principal Investigator
Massachusetts Eye and Ear
Are You a Good Fit for This Trial?
This trial is for individuals with severe Blepharoptosis, where one eyelid droops enough to block vision. Participants must have moderate or better cognitive function (score ≥18 on MMSE). Excluded are those with weak eye muscles, recent ptosis surgery, severe cognitive issues, mechanical causes of ptosis like tumors or scarring, and certain medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Crossover Treatment
Participants receive training and use each device at home for one week with daily follow-up by video calls
Washout Period
A washout period between the use of the two devices
Follow-up
Participants complete a questionnaire comparing the two devices and select their preferred device
What Are the Treatments Tested in This Trial?
Interventions
- Kinesiotape Frontalis Sling (KTFS)
- Magnetic Levator Prosthesis (MLP)
Trial Overview
The study compares two non-surgical devices: Magnetic Levator Prosthesis (MLP) and Kinesiotape Frontalis Sling (KTFS), both designed to help lift the eyelids in patients who can't fully open them due to various underlying conditions.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.
Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts Eye and Ear Infirmary
Lead Sponsor
National Eye Institute (NEI)
Collaborator
Citations
Conventional versus Modified Tarso-frontalis Suspension ...
They are commonly available and safe for frontalis suspension in patients with severe ptosis (Bansal and Sharma,. 2015). Postoperative functional outcomes.
A Double-Blind Randomized Crossover Trial of the Magnetic ...
Results : Of 14 enrolled thus far, 11 have completed the crossover. All 11 had acceptable improvement in ptosis and complete volitional blinks for all ...
A Double-Blind Randomized Crossover Trial of the ...
A double-blind randomized crossover trial of the magnetic levator prosthesis and kinesiotape frontalis sling for severe blepharoptosis.
4.
bmcophthalmol.biomedcentral.com
bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03371-3a new technique for long-term correction of severe congenital ...
This retrospective study reports the outcomes of two surgical techniques for treating severe congenital ptosis in the paediatric age group.
A Retrospective Analysis of the Efficacy of Silicone Sling in ...
They reported a recurrence rate of 7% within 22 months. Landau Prat et al. [23] assessed the outcome of frontalis sling surgery using silicone ...
a new technique for long-term correction of severe congenital ...
Preliminary results indicate promising outcomes for both techniques, with significant improvement in eyelid elevation observed in both groups.
Surgical Outcomes After Frontalis Suspension Using ...
ePTFE slings remain an excellent option for severe congenital ptosis repair with frontalis sling, demonstrating long-term functional success.
8.
bmcophthalmol.biomedcentral.com
bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03809-8Frontalis sling surgery - pediatric versus adult population
This study aims to compare the characteristics and outcomes of frontalis sling procedures for ptosis correction in these two age groups.
Farzana Afzal, et al. Outcome of Frontalis Brow Suspension ...
This procedure requires less surgical time, provides good cosmesis, less complication and early recovery. Keywords: Congenial Ptosis; Silicon ...
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