Fibrin Glue vs. Suture in Pterygium Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01158014
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):
Dr. Guy Ben-Simon, MD, Sheba Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Conjunctival Autograft Procedure: Fibrin Glue, Quixil Procedure: Suture Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fibrin Glue vs. Vicryl Suture in Pterygium Surgery With Conjunctival Auto-graft
Actual Study Start Date : January 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01158014

Ramat Gan, Israel, 52621
Sponsors and Collaborators
Dr. Guy Ben-Simon, MD

Publications of Results:
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
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Dr. Guy Ben-Simon, MD, Sheba Medical Center:
conjunctival graft
primary pterygium

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases
Fibrin Tissue Adhesive