Fibrin Glue vs. Suture in Pterygium Surgery

Not Applicable

Completed

• Conditions: Conjunctival Autograft
• Interventions: Procedure: Suture; Procedure: Fibrin Glue, Quixil

• Registration Number: NCT01158014
• Lead Sponsor: Dr. Guy Ben-Simon, MD

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.

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 Timeline

• Study First Submitted: 2010-07-04
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Study Start: 2014-01
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Suture	Conjunctival autograft will be sutured using 10/0 vicryl sutures to pterygia bed after removal
Fibrin Glue, surgery	Fibrin Glue, Quixil	Conjunctival autograft will be glued using fibrin glue to pterygia bed after removal

Primary Outcome Measures

Name	Time	Method
Pterygium recurrence	one year	Recurrence normally occurs 1-6 months after surgery. Success is achieved if ptergium does not recur after one year.

Secondary Outcome Measures

Name	Time	Method
operation time	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

Trial Locations

Locations (1)

Sheba_Medical_Center; 🇮🇱 Ramat Gan, Israel