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NCT03392272 Clinical Trial

Modified Müller's Muscle-conjunctival Resection Internal Ptosis Repair Using Fibrin Glue

Surgical Procedure, Unspecified Clinical Trial

Official title:
Modified Müller's Muscle-conjunctival Resection Internal Ptosis Repair Using Fibrin Glue

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03392272
Other study ID # SHEBA-17-4383-GBS
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 26, 2017
Last updated January 4, 2018
Start date February 1, 2018
Est. completion date February 1, 2020

Study information
Verified date January 2018
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Fibrin glue is widely used in ophthalmology for homeostasis and tissue recovery. It is commonly used in ocular surface surgeries such as pterygium removal and conjunctival lesions excisions. In Müller's muscle-conjunctival resection (MMCR), sutures are used to reconnect the conjunctiva and Muller muscle, which causes discomfort and pain for the patient. 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.

Description:

Fibrin glue is widely used in ophthalmology for homeostasis and tissue recovery. It is commonly used in ocular surface surgeries such as pterygium removal and conjunctival lesions excisions.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date February 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients with ptosis referred to Müller's Muscle-Conjunctival Resection (MMCR)

Exclusion Criteria:

Previous eyelid surgery

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Using of Tisseel fibrin glue
Using of Tisseel fibrin glue instead of sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
Other:
• Using sutures
Using sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries

Locations
Country Name City State
Israel Sheba_Medical_Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

Carruth BP, Meyer DR. Simplified Müller's muscle-conjunctival resection internal ptosis repair. Ophthal Plast Reconstr Surg. 2013 Jan-Feb;29(1):11-4. doi: 10.1097/IOP.0b013e31826afb6b. — View Citation

Liu MT, Totonchi A, Katira K, Daggett J, Guyuron B. Outcomes of mild to moderate upper eyelid ptosis correction using Müller's muscle-conjunctival resection. Plast Reconstr Surg. 2012 Dec;130(6):799e-809e. doi: 10.1097/PRS.0b013e31826d9cb0. — View Citation

Mercandetti M, Putterman AM, Cohen ME, Mirante JP, Cohen AJ. Internal levator advancement by Müller's muscle-conjunctival resection: technique and review. Arch Facial Plast Surg. 2001 Apr-Jun;3(2):104-10. — View Citation

Putterman AM, Urist MJ. Müller muscle-conjunctiva resection. Technique for treatment of blepharoptosis. Arch Ophthalmol. 1975 Aug;93(8):619-23. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pain level Pain grade using visual analogue scale of 0-10 with 0=no pain and 10=worst pain. until 2 weeks post op
Secondary successful ptosis correction satisfying improvement of margin to reflex distance 3 months
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