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Fibrin Glue vs. Suture in Pterygium Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Guy Ben-Simon, MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01158014
First received: July 4, 2010
Last updated: August 7, 2017
Last verified: August 2017
  Purpose
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: None (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 Dr. Guy Ben-Simon, MD, 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


Enrollment: 90
Actual Study Start Date: January 2014
Study Completion Date: June 2016
Primary Completion Date: May 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$) suffice for 10 cases, while one vicryl suture costs around 34 US$.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01158014

Locations
Israel
Sheba_Medical_Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Dr. Guy Ben-Simon, MD
  More Information

Publications:
Responsible Party: Dr. Guy Ben-Simon, MD, Prof, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01158014     History of Changes
Other Study ID Numbers: SHEBA-09-5033-GB-CTIL
Study First Received: July 4, 2010
Last Updated: August 7, 2017

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

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on September 21, 2017