NCT03392272

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

December 26, 2017

Last Update Submit

January 4, 2018

Conditions

Ptosis, EyelidPtosis; Eyelid, CongenitalSurgical Procedure, Unspecified

Keywords

PtosisMüller's Muscle-Conjunctival Resection (MMCR)Fibrin Glue

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • successful ptosis correction

    3 months

Study Arms (2)

Tisseel

EXPERIMENTAL

Müller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures

Device: Using of Tisseel fibrin glue

Sutures

ACTIVE COMPARATOR

Müller's Muscle-Conjunctival Resection (MMCR) using the usual procedure

Other: Using sutures

Interventions

Using of Tisseel fibrin glueDEVICE

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

Tisseel
Using suturesOTHER

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

Sutures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous eyelid surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba_Medical_Center

Ramat Gan, 52621, Israel

Location

Related Publications (5)

  • Putterman AM, Urist MJ. Muller muscle-conjunctiva resection. Technique for treatment of blepharoptosis. Arch Ophthalmol. 1975 Aug;93(8):619-23. doi: 10.1001/archopht.1975.01010020595007.

    PMID: 1156223BACKGROUND

  • Liu MT, Totonchi A, Katira K, Daggett J, Guyuron B. Outcomes of mild to moderate upper eyelid ptosis correction using Muller's muscle-conjunctival resection. Plast Reconstr Surg. 2012 Dec;130(6):799e-809e. doi: 10.1097/PRS.0b013e31826d9cb0.

    PMID: 23190831BACKGROUND

  • Mercandetti M, Putterman AM, Cohen ME, Mirante JP, Cohen AJ. Internal levator advancement by Muller's muscle-conjunctival resection: technique and review. Arch Facial Plast Surg. 2001 Apr-Jun;3(2):104-10. doi: 10.1001/archfaci.3.2.104.

    PMID: 11368662BACKGROUND

  • Carruth BP, Meyer DR. Simplified Muller's muscle-conjunctival resection internal ptosis repair. Ophthalmic Plast Reconstr Surg. 2013 Jan-Feb;29(1):11-4. doi: 10.1097/IOP.0b013e31826afb6b.

    PMID: 23034694BACKGROUND

  • Zloto O, Greenbaum E, Fabian ID, Ben Simon GJ. Evicel versus Tisseel versus Sutures for Attaching Conjunctival Autograft in Pterygium Surgery: A Prospective Comparative Clinical Study. Ophthalmology. 2017 Jan;124(1):61-65. doi: 10.1016/j.ophtha.2016.09.010. Epub 2016 Nov 3.

    PMID: 27817915BACKGROUND

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The physician will randomly assign the patient into the tisseel group or the sutures group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective randomized study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, oculoplastic unit

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 5, 2018

Study Start

February 1, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

January 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)