Modified Müller's Muscle-conjunctival Resection Internal Ptosis Repair Using Fibrin Glue
NCT ID: NCT03392272
Last Updated: 2018-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-02-01
2020-02-01
Brief Summary
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Detailed Description
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Müller's muscle-conjunctival resection (MMCR) is the most common surgery for ptosis correction and is normally performed under local anaesthesia. In MMCR, a portion of the Muller and conjunctiva is resected, and sutures are used to reconnect the remaining edges. The suturing process requires several minutes and causes discomfort to the patient. In addition, many patients experience post operative discomfort due to the touch of the sutures in the superior ocular surface until their removal about 7-14 days post op. Moreover, the sutures removal process is commonly unpleasant, and in the pediatric patients requires sedation or general anaesthesia.
The investigators' goal is to explore using fibrin glue instead of sutures in MMCR surgeries to shorten the procedure's length and alleviate patients discomfort and pain. This is especially important in the management of children suffering ptosis, where sedation and even general anaesthesia is required for sutured removal as a secondary procedure.
Methods:
A prospective randomized study. Patients will be randomized into traditional MMCR using sutures, vs. MMCR using tisseel glue. Follow up will take place 1 day, 7 days, 1 month and 3 months post op. Main outcome measures included patient reported outcome such as pain grade and discomfort, and success of ptosis repair surgery defined by improvement in margin reflex distance, symmetry of upper eyelid position, and incidence of complications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tisseel
Müller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures
Using of Tisseel fibrin glue
Using of Tisseel fibrin glue instead of sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
Sutures
Müller's Muscle-Conjunctival Resection (MMCR) using the usual procedure
Using sutures
Using sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
Interventions
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Using of Tisseel fibrin glue
Using of Tisseel fibrin glue instead of sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
Using sutures
Using sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Guy Ben-Simon, MD
Head, oculoplastic unit
Locations
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Sheba_Medical_Center
Ramat Gan, , Israel
Countries
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References
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Putterman AM, Urist MJ. Muller muscle-conjunctiva resection. Technique for treatment of blepharoptosis. Arch Ophthalmol. 1975 Aug;93(8):619-23. doi: 10.1001/archopht.1975.01010020595007.
Liu MT, Totonchi A, Katira K, Daggett J, Guyuron B. Outcomes of mild to moderate upper eyelid ptosis correction using Muller's muscle-conjunctival resection. Plast Reconstr Surg. 2012 Dec;130(6):799e-809e. doi: 10.1097/PRS.0b013e31826d9cb0.
Mercandetti M, Putterman AM, Cohen ME, Mirante JP, Cohen AJ. Internal levator advancement by Muller's muscle-conjunctival resection: technique and review. Arch Facial Plast Surg. 2001 Apr-Jun;3(2):104-10. doi: 10.1001/archfaci.3.2.104.
Carruth BP, Meyer DR. Simplified Muller's muscle-conjunctival resection internal ptosis repair. Ophthalmic Plast Reconstr Surg. 2013 Jan-Feb;29(1):11-4. doi: 10.1097/IOP.0b013e31826afb6b.
Zloto O, Greenbaum E, Fabian ID, Ben Simon GJ. Evicel versus Tisseel versus Sutures for Attaching Conjunctival Autograft in Pterygium Surgery: A Prospective Comparative Clinical Study. Ophthalmology. 2017 Jan;124(1):61-65. doi: 10.1016/j.ophtha.2016.09.010. Epub 2016 Nov 3.
Other Identifiers
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SHEBA-17-4383-GBS
Identifier Type: -
Identifier Source: org_study_id
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