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

S

Sheba Medical Center

Status

Unknown

Conditions

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

Treatments

Other: Using sutures
Device: Using of Tisseel fibrin glue

Study type

Interventional

Funder types

Other

Identifiers

NCT03392272
SHEBA-17-4383-GBS

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Previous eyelid surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Tisseel
Experimental group
Description:
Müller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures
Treatment:
Device: Using of Tisseel fibrin glue
Sutures
Active Comparator group
Description:
Müller's Muscle-Conjunctival Resection (MMCR) using the usual procedure
Treatment:
Other: Using sutures

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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