Intraductal Meibomian Gland Probing Trial
MGP
Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction
1 other identifier
interventional
45
1 country
1
Brief Summary
In this research study, the investigators are looking at the effects of Meibomian Gland Probing (MGP) versus a sham (fake) procedure in patients with refractory MGD who have already tried traditional management with no success in resolving their clinical signs (as seen by their ophthalmologist) or their symptoms. The investigators are also evaluating the effects of using two (2) post-procedural medication treatments: Blephamide or GenTeal PM Night-Time to determine if treatment after the MGP procedure has an effect on its outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
May 22, 2017
CompletedJune 19, 2017
May 1, 2017
10 months
August 13, 2014
April 14, 2017
May 25, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Ocular Surface Disease Index (OSDI)
A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
4 week Time Point
Symptom Assessment in Dry Eye (SANDE)
A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
4 week Time Point
Corneal Fluorescein Staining (CFS)
Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.
4 week Time Point
Tear Break Up Time (TBUT)
TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.
4 week Time Point
Study Arms (3)
Meibomian Gland Probing plus lubricant
OTHERMeibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands. Lubricant: GenTeal PM Night-Time Ointment (Alcon), a sterile ophthalmic lubricant that is commonly used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks with the following regimen: twice daily for 2 weeks and then once daily for 2 weeks.
Sham Meibomian Gland Probing plus lubricant
OTHERSham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring. Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.
Meibomian Gland Probing plus Blephamide
ACTIVE COMPARATORMeibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands. Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.
Interventions
For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. After obtaining adequate anesthesia, the solid stainless steel probes (Maskin® Meibomian Gland Intraductal Probes, Rhein Medical Inc.) were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were initially be probed with a 1-mm probe followed by a 2-mm probe for all glands.
For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. The patient's lid margin was touched with the probes without actual probing of the meibomian gland orifices.
Eligibility Criteria
You may qualify if:
- Age 18-89 years
- Willing and able to provide written informed consent
- Willing and able to comply with study assessments for the full duration of the study
- Diagnosis of meibomian gland dysfunction (MGD)
- Symptoms of MGD such as foreign body sensation, burning, stinging, light sensitivity for at least 3 months
- Persistent symptoms despite at least 3 months of medical management including lid hygiene, warm compress, and use of topical and systemic therapy, or contraindication to systemic therapy
- Presence of lid tenderness on the upper lids in both eyes
- Tear break-up time (TBUT) of \<10 seconds
- In good stable overall health
You may not qualify if:
- Active allergies to steroids, sulfacetamide, GenTeal PM Night-Time ointment, or lidocaine
- Intraocular surgery or ocular laser surgery within 1 month before enrollment
- History of ocular infection within 1 month before enrollment.
- History of increased intraocular pressure after using topical steroids (steroid responsive)
- Any condition (including language barrier) that precludes subject's ability to comply with study requirements including completion of study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
Related Publications (1)
Kheirkhah A, Kobashi H, Girgis J, Jamali A, Ciolino JB, Hamrah P. A randomized, sham-controlled trial of intraductal meibomian gland probing with or without topical antibiotic/steroid for obstructive meibomian gland dysfunction. Ocul Surf. 2020 Oct;18(4):852-856. doi: 10.1016/j.jtos.2020.08.008. Epub 2020 Aug 31.
PMID: 32882429DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Assistant Professor of Ophthalmology
- Organization
- Massachusetts Eye and Ear Infirmary
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph B Ciolino, M. D.
Massachusetts Eye and Ear Infirmary
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Ophthalmology
Study Record Dates
First Submitted
August 13, 2014
First Posted
October 6, 2014
Study Start
October 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
June 19, 2017
Results First Posted
May 22, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share