Fibrin Glue vs. Suture in Pterygium Surgery

Conjunctival Autograft Clinical Trial

Official title:

Fibrin Glue vs. Vicryl Suture in Pterygium Surgery With Conjunctival Auto-graft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158014
• Other study ID #: SHEBA-09-5033-GB-CTIL
• Status: Completed
• Phase: N/A
• First received: July 4, 2010
• Last updated: August 7, 2017
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2017
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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$) suffice for 10 cases, while one vicryl suture costs around 34 US$.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• primary pterygium

• healthy subject

• ability to attend follow-up visits

Exclusion Criteria:

• recurrent pterygium

• underwent previous surgery / intervention to treat pterygium

• ocular surface disease 0 minor

Related Conditions & MeSH terms

• Conjunctival Autograft
• Pterygium

Intervention

Procedure:
• Fibrin Glue, Quixil
quixil 0.1 ml
• Suture
vicryl 10/0

Locations

Country	Name	City	State
Israel	Sheba_Medical_Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Guy Ben-Simon, MD

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Hall 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. — View Citation

Por YM, Tan DT. Assessment of fibrin glue in pterygium surgery. Cornea. 2010 Jan;29(1):1-4. doi: 10.1097/ICO.0b013e3181a38fda. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pterygium recurrence	Recurrence normally occurs 1-6 months after surgery. Success is achieved if ptergium does not recur after one year.	one year
Secondary	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	one year