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Non-Surgical Treatments for Drooping Eyelid

N/A
Recruiting
Led By Kevin Houston, OD MSc
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of ptosis for at least one eye which occludes the visual axis in the resting position (without frontalis drive, lifting with forehead muscles)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of the one-week period of home use of the second device
Awards & highlights

Study Summary

This trial will compare two devices to see which is better at improving eye lid opening for patients with severe Blepharoptosis.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include skin irritation from device contact, discomfort during use, possible allergic reactions to materials in the devices, and fatigue of forehead muscles from compensatory lifting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a droopy eyelid that covers my eye even when I'm not raising my eyebrows.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after)
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference between MLP and KTFS in the change in interpalpebral fissure during opening and spontaneous blinking
Secondary outcome measures
Difference between MLP and KTFS in the changes in interpalpebral fissure during volitional blinking
Proportion of subjects selecting each device

Trial Design

2Treatment groups
Experimental Treatment
Group I: MLP first, KTFS secondExperimental Treatment2 Interventions
Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.
Group II: KTFS first, MLP secondExperimental Treatment2 Interventions
Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor
106 Previous Clinical Trials
12,899 Total Patients Enrolled
National Eye Institute (NEI)NIH
547 Previous Clinical Trials
1,402,107 Total Patients Enrolled
Kevin Houston, OD MScPrincipal Investigator - Massachusetts Eye and Ear
Massachusetts Eye & Ear Infirmary

Media Library

Kinesiotape Frontalis Sling (KTFS) Clinical Trial Eligibility Overview. Trial Name: NCT04678115 — N/A
Drooping Eyelid Research Study Groups: MLP first, KTFS second, KTFS first, MLP second
Drooping Eyelid Clinical Trial 2023: Kinesiotape Frontalis Sling (KTFS) Highlights & Side Effects. Trial Name: NCT04678115 — N/A
Kinesiotape Frontalis Sling (KTFS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04678115 — N/A

Frequently Asked Questions

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

Are there any open vacancies for individuals interested in participating in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical evaluation was introduced on June 1st 2021 and is currently recruiting for 50 individuals from a single centre. The last update occurred on October 7th 2022."

Answered by AI

What is the size of this research cohort?

"Correct. According to the information hosted on clinicaltrials.gov, this medical trial is actively recruiting patients with initial postings going up on June 1st 2021 and most recent updates occurring October 7th 2022. A total of 50 individuals need to be recruited from one site for completion of the study."

Answered by AI

Who else is applying?

How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Massachusetts Eye and Ear
Recent research and studies
clinicaltrials.govStudy
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Kevin Houston 2021. "Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04678115.
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