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Fibrin Glue vs. Suture in Pterygium Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Sheba Medical Center
Information provided by (Responsible Party):
Dr. Guy Ben-Simon, MD, Sheba Medical Center Identifier:
First received: July 4, 2010
Last updated: November 30, 2015
Last verified: November 2015
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.

Condition Intervention
Conjunctival Autograft
Procedure: Fibrin Glue, Quixil
Procedure: Suture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fibrin Glue vs. Vicryl Suture in Pterygium Surgery With Conjunctival Auto-graft

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • operation time [ Time Frame: one year ]
    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

Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibrin Glue, surgery
Conjunctival autograft will be glued using fibrin glue to pterygia bed after removal
Procedure: Fibrin Glue, Quixil
quixil 0.1 ml
Active Comparator: Control
Conjunctival autograft will be sutured using 10/0 vicryl sutures to pterygia bed after removal
Procedure: Suture
vicryl 10/0

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


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01158014

Contact: Guy J Ben Simon, MD 972509716632
Contact: Mordechai Rosner, MD 972526667242

Sheba_Medical_Center Recruiting
Ramat Gan, Israel, 52621
Contact: Guy J Ben Simon, MD    97235302874   
Contact: Mordechai Rosner, MD    972526667242   
Principal Investigator: Guy J Ben Simon, MD         
Sub-Investigator: Mordechai Rosner, MD         
Sub-Investigator: Nachum Rosen, MD         
Sponsors and Collaborators
Dr. Guy Ben-Simon, MD
  More Information

Responsible Party: Dr. Guy Ben-Simon, MD, Prof, Sheba Medical Center Identifier: NCT01158014     History of Changes
Other Study ID Numbers: SHEBA-09-5033-GB-CTIL
Study First Received: July 4, 2010
Last Updated: November 30, 2015

Keywords provided by Sheba Medical Center:
conjunctival graft
primary pterygium

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases
Fibrin Tissue Adhesive
Coagulants processed this record on May 25, 2017