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Fibrin Glue vs. Suture in Pterygium Surgery

D

Dr. Guy Ben-Simon, MD

Status

Completed

Conditions

Conjunctival Autograft

Treatments

Procedure: Suture
Procedure: Fibrin Glue, Quixil

Study type

Interventional

Funder types

Other

Identifiers

NCT01158014
SHEBA-09-5033-GB-CTIL

Details and patient eligibility

About

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.

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

Enrollment

90 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Fibrin Glue, surgery
Experimental group
Description:
Conjunctival autograft will be glued using fibrin glue to pterygia bed after removal
Treatment:
Procedure: Fibrin Glue, Quixil
Control
Active Comparator group
Description:
Conjunctival autograft will be sutured using 10/0 vicryl sutures to pterygia bed after removal
Treatment:
Procedure: Suture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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