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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Using of Tisseel fibrin glue
* Other: Using sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ptosis referred to Müller's Muscle-Conjunctival Resection (MMCR) Exclusion Criteria: Previous eyelid surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tisseel<br>Müller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures | Device: Using of Tisseel fibrin glue<br>* Using of Tisseel fibrin glue instead of sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries<br>|
| Active Comparator: Sutures<br>Müller's Muscle-Conjunctival Resection (MMCR) using the usual procedure | Other: Using sutures<br>* Using sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful ptosis correction | satisfying improvement of margin to reflex distance | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ptosis, Müller's Muscle-Conjunctival Resection (MMCR), Fibrin Glue