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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03392272
Enrollment
50
Registered
2018-01-05
Start date
2018-02-01
Completion date
2020-02-01
Last updated
2018-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

DEVICEUsing of Tisseel fibrin glue

Using of Tisseel fibrin glue instead of sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries

OTHERUsing sutures

Using sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

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

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Previous eyelid surgery

Design outcomes

Primary

MeasureTime frameDescription
Pain leveluntil 2 weeks post opPain grade using visual analogue scale of 0-10 with 0=no pain and 10=worst pain.

Secondary

MeasureTime frameDescription
successful ptosis correction3 monthssatisfying improvement of margin to reflex distance

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026