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

Not Applicable

• Conditions: Surgical Procedure, Unspecified; Ptosis, Eyelid; Ptosis; Eyelid, Congenital
• Interventions: Device: Using of Tisseel fibrin glue; Other: Using sutures

• Registration Number: NCT03392272
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study First Submitted: 2017-12-26
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-04
• Last Update Submitted: 2018-01-04
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-05
• Study Start: 2018-02-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

Previous eyelid surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tisseel	Using of Tisseel fibrin glue	Müller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures
Sutures	Using sutures	Müller's Muscle-Conjunctival Resection (MMCR) using the usual procedure

Primary Outcome Measures

Name	Time	Method
Pain level	until 2 weeks post op	Pain grade using visual analogue scale of 0-10 with 0=no pain and 10=worst pain.

Secondary Outcome Measures

Name	Time	Method
successful ptosis correction	3 months	satisfying improvement of margin to reflex distance

Trial Locations

Locations (1)

Sheba_Medical_Center; 🇮🇱 Ramat Gan, Israel