Magnetic Levator Prosthesis (MLP) for Blepharoptosis

Phase-Based Estimates
1
Effectiveness
1
Safety
Schepens Eye Research Institute, Boston, MA
Blepharoptosis+5 More
Magnetic Levator Prosthesis (MLP) - Device
Eligibility
Any Age
All Sexes
Eligible conditions
Blepharoptosis

Study Summary

This study is evaluating whether a magnetic device can help improve eyelid movement for individuals with blepharoptosis.

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Eligible Conditions

  • Blepharoptosis
  • Stroke
  • Brain Injuries
  • Brain Injuries, Traumatic
  • Myasthenia Gravis
  • Traumatic Brain Injury (TBI)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Magnetic Levator Prosthesis (MLP) will improve 1 primary outcome and 1 secondary outcome in patients with Blepharoptosis. Measurement will happen over the course of This outcome will be analysed by reviewing video recording. Video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2).

This outcome will be analysed by reviewing video recording. Video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2)
Change in interpalpebral fissure during eye opening
Video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2)
Change in interpalpebral fissure during the blink

Trial Safety

Trial Design

2 Treatment Groups

Control
Experimental Group

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Magnetic Levator Prosthesis (MLP) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group
Device
The purpose of the experimental group is to test the intervention. Participants will have their acuity measured (refraction as needed), slit lamp with Nafl & NEI scale, visual functioning questionnaire (VFQ), cognitive assessment (MOCA).The eye lid will be prepped and video recorded.The masked clinical staff will then apply the polarized magnets and perform a number of measurements to ascertain effectiveness of intervention. -Intervention - Magnetic Levator Prosthesis (MLP)
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2) for reporting.

Who is running the study

Principal Investigator
K. H.
Prof. Kevin Houston, Assistant Professor of Ophthalmology
Massachusetts Eye and Ear Infirmary

Closest Location

Schepens Eye Research Institute - Boston, MA

Eligibility Criteria

This trial is for patients born any sex of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
(MMSE) is required to be included in the study To be included in the study, a person must have a moderate cognitive function or better, which is defined as having a score of 18 or more out of 30 on a pre-screening of the Mini-Mental State Exam (MMSE). show original
The person has a droopy eyelid that covers their visual field in the resting position, without using their forehead muscles to lift the eyelid. show original
and results in enophthalmos The ptosis obscures the visual axis and results in enophthalmos. show original
Age 18 or older
Age 5 or older

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get blepharoptosis a year in the United States?

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Results from a recent paper of a study from Sweden suggest that 5.9% of men aged 40 to 69 years and 5.3% of women aged 60 and over report having had some amount of blepharoptosis. A high percentage of people with blepharoptosis are dissatisfied with the appearance of their eyes. Further research is required to explore the causal mechanism in blepharoptosis and its potential impact on daily life.

Unverified Answer

What are the signs of blepharoptosis?

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Signs of blepharoptosis include a drooped eyebrows, thin eyebrows, a lack of the lower eyelashes or alopecia of the eyebrows. Blepharoptosis can range from the mild form to the severe variety.

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What is blepharoptosis?

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Blepharoptosis is a disease of facial appearance characterised by the drooping of the lower eyelid and the associated eyelid retraction. A considerable number of adults and children are affected. The pathogenesis of blepharoptosis is unknown. In the study, the eyelid position was compared pre-operatively and post-operatively. Results from a recent paper showed that the severity of the blepharoptosis was reduced after surgery and that the eyelids returned to a normal position. Blepharoptosis is a common disease associated with aging and women are most commonly affected. The use of eye drops for the application of artificial tears or eye ointments post-operatively does not appear to help the condition.

Unverified Answer

Can blepharoptosis be cured?

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Blepharoconjunctivitis, which is caused by an imbalance in septal cartilage function, is a condition that may result from blepharoplastosis. Treatment of blepharoconjunctivitis involves removal of blepharoplastosis.

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What are common treatments for blepharoptosis?

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The most common treatment for blepharoptosis is bimatoprost, which is a synthetic analogue of the naturally occurring PTGF-B. Other solutions may include eye hygiene and massage, taping at the bottom of the eyelid, blepharoplasty, and laser hair removal. summary: This article discusses what is commonly accomplished by physicians and surgeons for the treatment of wrinkles.

Unverified Answer

What causes blepharoptosis?

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Nerve injuries may cause permanent alterations in the function of nerves controlling the levator palpebrae superioris muscle. The result may be a temporary or permanent one, but the cosmetic impact is normally acceptable.

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Is magnetic levator prosthesis (mlp) typically used in combination with any other treatments?

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Patients treated with MLP plus eyelid surgery (blepharoplasty), especially if they have also been treated with other forms of correction, are likely to have improved postoperative eyelid position.

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Has magnetic levator prosthesis (mlp) proven to be more effective than a placebo?

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The MLP technique is an effective procedure in treating patients with blepharoptosis. For this procedure, the MLP technique was more effective than a placebo, and was shown to be an effective and safe option in the treatment of blepharoptosis.

Unverified Answer

What are the latest developments in magnetic levator prosthesis (mlp) for therapeutic use?

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Although early use of a magnetic sleeve with the prosthesis led to improvement in the function of the eyelids in patients with blepharoptosis, this has not been proven in randomized controlled trials. However, in view of the favourable findings in other trials, magnetic prostheses that have become commercially available are an alternative treatment option for blepharoptosis and other eyelid complaints and may be a valuable treatment modality.

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What are the chances of developing blepharoptosis?

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Blepharoptosis is rare. A small number of patients are susceptible to develop blepharoptosis. There are no statistical differences between genders and ages for the development of blepharoptosis. However, there may be a correlation between blepharoptosis and diseases. Therefore, there will be more research done on blepharoptosis with larger sample sizes.

Unverified Answer

What is the primary cause of blepharoptosis?

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There was a higher rate of blepharoptosis in both females (3.25%) and males (3.5%) who had blepharoplasties. The rate of blepharoptosis in these patients was not dependent upon surgical approach (trans-sphenoidal vs. trans-palpebral) or in age (>60 yrs.), but is most likely related to ptosis surgery.

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What are the common side effects of magnetic levator prosthesis (mlp)?

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Considering all our patients, [the most common adverse side effects are listed in table (1)] and [MLP is considered a minimally invasive procedure with a very low risk of complications. So in the following days if you have any issues, it is very important to talk to your doctor.

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