Conjunctival AutograftNCT01158014
Fibrin Glue vs. Suture in Pterygium Surgery
A study testing Fibrin Glue, Quixil and Suture in people with Conjunctival Autograft, run by Dr. Guy Ben-Simon, MD at 1 site in Israel.
Trial summary
The use of Fibrin glue to place conjunctival graft will be as effective as suturing the graft, but will require much less operative time and will be better tolerated by the patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Conjunctival Autograft
- What is being tested?
- Fibrin Glue, Quixil and Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jun 2016
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary pterygium
- healthy subject
- ability to attend follow-up visits
Who cannot join
- recurrent pterygium
- underwent previous surgery / intervention to treat pterygium
- ocular surface disease 0 minor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fibrin Glue vs. Vicryl Suture in Pterygium Surgery With Conjunctival Auto-graft
The use of Fibrin glue to place conjunctival graft will be as effective as suturing the graft, but will require much less operative time and will be better tolerated by the patients.
Read the detailed description
Pterygium surgery requires removal of the pterygia from cornea and conjunctiva and an additional technique to prevent recurrence which may be as high as 50%.
Suturing a conjunctival auto-graft has become one of the most popular and effective methods in preventing recurrence. However suturing requires long operative time (10-20 minutes with removal alone less than 5 minutes) and requires sutures removal after 1-2 weeks which is very inconvenient to the patient.
Using Fibrin Glue (Quixil) has been used in several places in pterygium surgery and we believe it will be as effective as suturing the graft, will use much less OR time (reduce surgery time from 40 minutes to 20-25 minutes) and will be less expensive since 2 ml glue (around 80US$) suffice for 10 cases, while one vicryl suture costs around 34 US$.
- Conditions
- Conjunctival Autograft
- Being tested
- Fibrin Glue, Quixil, Suture
- Keywords
- pterygium, conjunctival graft, recurrence, primary pterygium
- Medical subject headings
- Pterygium, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Glue, QuixilProcedure or surgery
quixil 0.1 ml
SutureProcedure or surgery
vicryl 10/0
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Glue, surgery | Experimental | Conjunctival autograft will be glued using fibrin glue to pterygia bed after removal Receives: Procedure: Fibrin Glue, Quixil |
| Control | Active comparator | Conjunctival autograft will be sutured using 10/0 vicryl sutures to pterygia bed after removal Receives: Procedure: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pterygium recurrence
Recurrence normally occurs 1-6 months after surgery. Success is achieved if ptergium does not recur after one year.
Measured: one year
Secondary outcomes (1)
operation time
suturing a conjunctival graft takes 15-10 minutes while gluing only 5 minutes, we believe that by lowering OR time, total costs of surgery are less
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Conjunctival AutograftStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Guy Ben-Simon, MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr. Guy Ben-Simon, MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158014
- Sponsor's protocol ID
- SHEBA-09-5033-GB-CTIL
- Status last verified
- Aug 2017
- First submitted
- 4 Jul 2010
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ratnalingam V, Eu AL, Ng GL, Taharin R, John E. Fibrin adhesive is better than sutures in pterygium surgery. Cornea. 2010 May;29(5):485-9. doi: 10.1097/ICO.0b013e3181c29696.
PubMed 20308876Por YM, Tan DT. Assessment of fibrin glue in pterygium surgery. Cornea. 2010 Jan;29(1):1-4. doi: 10.1097/ICO.0b013e3181a38fda.
PubMed 19907303Hall RC, Logan AJ, Wells AP. Comparison of fibrin glue with sutures for pterygium excision surgery with conjunctival autografts. Clin Exp Ophthalmol. 2009 Aug;37(6):584-9. doi: 10.1111/j.1442-9071.2009.02105.x.
PubMed 19702708
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrin Glue vs. Vicryl Suture in Pterygium Surgery With Conjunctival Auto-graft
- ClinicalTrials.gov ID
- NCT01158014
- Acronym / sponsor ID
- SHEBA-09-5033-GB-CTIL
- Conditions
- Conjunctival Autograft
- Keywords
- pterygium, conjunctival graft, recurrence, primary pterygium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr. Guy Ben-Simon, MDOther government
- Study start
- Jan 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Jul 2010 (estimated)
- 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.
The use of Fibrin glue to place conjunctival graft will be as effective as suturing the graft, but will require much less operative time and will be better tolerated by the patients.
Detailed description
Pterygium surgery requires removal of the pterygia from cornea and conjunctiva and an additional technique to prevent recurrence which may be as high as 50%.
Suturing a conjunctival auto-graft has become one of the most popular and effective methods in preventing recurrence. However suturing requires long operative time (10-20 minutes with removal alone less than 5 minutes) and requires sutures removal after 1-2 weeks which is very inconvenient to the patient.
Using Fibrin Glue (Quixil) has been used in several places in pterygium surgery and we believe it will be as effective as suturing the graft, will use much less OR time (reduce surgery time from 40 minutes to 20-25 minutes) and will be less expensive since 2 ml glue (around 80US$) suffice for 10 cases, while one vicryl suture costs around 34 US$.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin Glue, surgery | Experimental | Procedure: Fibrin Glue, QuixilConjunctival autograft will be glued using fibrin glue to pterygia bed after removal |
| Control | Active comparator | Procedure: SutureConjunctival autograft will be sutured using 10/0 vicryl sutures to pterygia bed after removal |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary pterygium
- healthy subject
- ability to attend follow-up visits
Key exclusion criteria (3 listed)
- recurrent pterygium
- underwent previous surgery / intervention to treat pterygium
- ocular surface disease 0 minor
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 |
|---|---|---|
| Fibrin Glue, Quixilquixil 0.1 ml | Procedure or surgery | Fibrin Glue, surgery |
| Suturevicryl 10/0 | Procedure or surgery | Control |
Primary outcome
Pterygium recurrence
Time frame: one year
Recurrence normally occurs 1-6 months after surgery. Success is achieved if ptergium does not recur after one year.
1 secondary outcome
operation time
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Results publication: PubMed 20308876Ratnalingam V, Eu AL, Ng GL, Taharin R, John E. Fibrin adhesive is better than sutures in pterygium surgery. Cornea. 2010 May;29(5):485-9. doi: 10.1097/ICO.0b013e3181c29696.
- Results publication: PubMed 19907303Por YM, Tan DT. Assessment of fibrin glue in pterygium surgery. Cornea. 2010 Jan;29(1):1-4. doi: 10.1097/ICO.0b013e3181a38fda.
- Results publication: PubMed 19702708Hall RC, Logan AJ, Wells AP. Comparison of fibrin glue with sutures for pterygium excision surgery with conjunctival autografts. Clin Exp Ophthalmol. 2009 Aug;37(6):584-9. doi: 10.1111/j.1442-9071.2009.02105.x.
Related trials for Conjunctival Autograft
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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 Fibrin Glue, Quixil and Suture in people with Conjunctival Autograft, run by Dr. Guy Ben-Simon, MD 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pterygium recurrence (time frame: one year). 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 NCT01158014, which also lists 3 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 8 Aug 2017.