Ptosis, Eyelid, Ptosis; Eyelid, Congenital, Surgical Procedure, Unspecified
Conditions
Keywords
Ptosis, Müller's Muscle-Conjunctival Resection (MMCR), Fibrin Glue
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.
Interventions
Using of Tisseel fibrin glue instead of sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
Using sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
Sponsors
Study design
Masking description
The physician will randomly assign the patient into the tisseel group or the sutures group
Intervention model description
A prospective randomized study
Eligibility
Inclusion criteria
Patients with ptosis referred to Müller's Muscle-Conjunctival Resection (MMCR)
Exclusion criteria
Previous eyelid surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| successful ptosis correction | 3 months | satisfying improvement of margin to reflex distance |
Countries
Israel