Ptosis, EyelidNCT03392272
Modified Müller's Muscle-conjunctival Resection Internal Ptosis Repair Using Fibrin Glue
A study testing Using of Tisseel fibrin glue and Using sutures in people with Ptosis, Eyelid and Ptosis; Eyelid, Congenital, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ptosis, Eyelid, Ptosis; Eyelid, Congenital, Surgical Procedure, Unspecified
- What is being tested?
- Using of Tisseel fibrin glue and Using sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2018to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ptosis referred to Müller's Muscle-Conjunctival Resection (MMCR)
Who cannot join
- Previous eyelid surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Using of Tisseel fibrin glue, Using sutures
- Keywords
- Ptosis, Müller's Muscle-Conjunctival Resection (MMCR), Fibrin Glue
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using of Tisseel fibrin glueDevice
Using of Tisseel fibrin glue instead of sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
Using suturesOther
Using sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
| Study group | Role | What they receive |
|---|---|---|
| Tisseel | Experimental | Müller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures Receives: Device: Using of Tisseel fibrin glue |
| Sutures | Active comparator | Müller's Muscle-Conjunctival Resection (MMCR) using the usual procedure Receives: Other: Using sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Pain grade using visual analogue scale of 0-10 with 0=no pain and 10=worst pain.
Measured: until 2 weeks post op
Secondary outcomes (1)
successful ptosis correction
satisfying improvement of margin to reflex distance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start1 Feb 2018 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ptosis, EyelidStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized study
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Guy Ben-Simon, MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392272
- Sponsor's protocol ID
- SHEBA-17-4383-GBS
- Status last verified
- Jan 2018
- First submitted
- 26 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 1156223Liu 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.
PubMed 23190831Mercandetti 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.
PubMed 11368662Carruth 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.
PubMed 23034694Zloto 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.
PubMed 27817915
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Müller's Muscle-conjunctival Resection Internal Ptosis Repair Using Fibrin Glue
- ClinicalTrials.gov ID
- NCT03392272
- Acronym / sponsor ID
- SHEBA-17-4383-GBS
- Keywords
- Ptosis, Müller's Muscle-Conjunctival Resection (MMCR), Fibrin Glue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- A prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| Tisseel | Experimental | Device: Using of Tisseel fibrin glueMüller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures |
| Sutures | Active comparator | Other: Using suturesMüller's Muscle-Conjunctival Resection (MMCR) using the usual procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ptosis referred to Müller's Muscle-Conjunctival Resection (MMCR)
Key exclusion criteria (1 listed)
- Previous eyelid surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using of Tisseel fibrin glueUsing of Tisseel fibrin glue instead of sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries | Device | Tisseel |
| Using suturesUsing sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries | Other | Sutures |
Primary outcome
Pain level
Time frame: until 2 weeks post op
Pain grade using visual analogue scale of 0-10 with 0=no pain and 10=worst pain.
1 secondary outcome
successful ptosis correction
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Background: PubMed 1156223Putterman 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.
- Background: PubMed 23190831Liu 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.
- Background: PubMed 11368662Mercandetti 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.
- Background: PubMed 23034694Carruth 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.
- Background: PubMed 27817915Zloto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using of Tisseel fibrin glue and Using sutures in people with Ptosis, Eyelid and Ptosis; Eyelid, Congenital, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: until 2 weeks post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03392272, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.