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OpenTrials
Completed

NCT Number: NCT01158014

Fibrin Glue vs. Suture in Pterygium Surgery

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.

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Key information

Conditions

Conjunctival Autograft Conjunctival Diseases Disease Attributes Eye Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pterygium Recurrence

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba_Medical_Center

Ramat Gan, 52621, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibrin Glue, Quixil

Procedure

quixil 0.1 ml

Suture

Procedure

vicryl 10/0

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dr. Guy Ben-Simon, MD

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 8, 2010
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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