An interventional study of Using of Tisseel fibrin glue and Using sutures in Ptosis, Eyelid, Ptosis; Eyelid, Congenital and Surgical Procedure, Unspecified, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-05.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
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.
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.
75 studies on the registry are indexed under Blepharoptosis; 14 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 56 interventional studies indexed under Blepharoptosis.
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Patients with ptosis referred to Müller's Muscle-Conjunctival Resection (MMCR)
Exclusion Criteria:
Previous eyelid surgery
Müller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures
Device: Using of Tisseel fibrin glue
Müller's Muscle-Conjunctival Resection (MMCR) using the usual procedure
Other: Using sutures
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
Pain level
Pain grade using visual analogue scale of 0-10 with 0=no pain and 10=worst pain.
Time frame: until 2 weeks post op
successful ptosis correction
satisfying improvement of margin to reflex distance
Time frame: 3 months
Plan to share: No
Start is estimated for Feb 2018; primary completion for Feb 2020, 24 months later.
Of 24 interventional studies with no phase under Blepharoptosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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