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

Primary Purpose

Ptosis, Eyelid, Ptosis; Eyelid, Congenital, Surgical Procedure, Unspecified

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Using of Tisseel fibrin glue
Using sutures
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ptosis, Eyelid focused on measuring Ptosis, Müller's Muscle-Conjunctival Resection (MMCR), Fibrin Glue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Previous eyelid surgery

Sites / Locations

  • Sheba_Medical_Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tisseel

Sutures

Arm Description

Müller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures

Müller's Muscle-Conjunctival Resection (MMCR) using the usual procedure

Outcomes

Primary Outcome Measures

Pain level
Pain grade using visual analogue scale of 0-10 with 0=no pain and 10=worst pain.

Secondary Outcome Measures

successful ptosis correction
satisfying improvement of margin to reflex distance

Full Information

First Posted
December 26, 2017
Last Updated
January 4, 2018
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03392272
Brief Title
Modified Müller's Muscle-conjunctival Resection Internal Ptosis Repair Using Fibrin Glue
Official Title
Modified Müller's Muscle-conjunctival Resection Internal Ptosis Repair Using Fibrin Glue
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptosis, Eyelid, Ptosis; Eyelid, Congenital, Surgical Procedure, Unspecified
Keywords
Ptosis, Müller's Muscle-Conjunctival Resection (MMCR), Fibrin Glue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective randomized study
Masking
Care Provider
Masking Description
The physician will randomly assign the patient into the tisseel group or the sutures group
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tisseel
Arm Type
Experimental
Arm Description
Müller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures
Arm Title
Sutures
Arm Type
Active Comparator
Arm Description
Müller's Muscle-Conjunctival Resection (MMCR) using the usual procedure
Intervention Type
Device
Intervention Name(s)
Using of Tisseel fibrin glue
Intervention Description
Using of Tisseel fibrin glue instead of sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
Intervention Type
Other
Intervention Name(s)
Using sutures
Intervention Description
Using sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
Primary Outcome Measure Information:
Title
Pain level
Description
Pain grade using visual analogue scale of 0-10 with 0=no pain and 10=worst pain.
Time Frame
until 2 weeks post op
Secondary Outcome Measure Information:
Title
successful ptosis correction
Description
satisfying improvement of margin to reflex distance
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ptosis referred to Müller's Muscle-Conjunctival Resection (MMCR) Exclusion Criteria: Previous eyelid surgery
Facility Information:
Facility Name
Sheba_Medical_Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1156223
Citation
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.
Results Reference
background
PubMed Identifier
23190831
Citation
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.
Results Reference
background
PubMed Identifier
11368662
Citation
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.
Results Reference
background
PubMed Identifier
23034694
Citation
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.
Results Reference
background
PubMed Identifier
27817915
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.
Results Reference
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Modified Müller's Muscle-conjunctival Resection Internal Ptosis Repair Using Fibrin Glue

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