Fibrin Glue vs. Suture in Pterygium Surgery

NCT ID: NCT01158014

Last Updated: 2017-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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

Conditions

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Conjunctival Autograft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fibrin Glue, surgery

Conjunctival autograft will be glued using fibrin glue to pterygia bed after removal

Group Type EXPERIMENTAL

Fibrin Glue, Quixil

Intervention Type PROCEDURE

quixil 0.1 ml

Control

Conjunctival autograft will be sutured using 10/0 vicryl sutures to pterygia bed after removal

Group Type ACTIVE_COMPARATOR

Suture

Intervention Type PROCEDURE

vicryl 10/0

Interventions

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Fibrin Glue, Quixil

quixil 0.1 ml

Intervention Type PROCEDURE

Suture

vicryl 10/0

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Guy Ben-Simon, MD

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Guy Ben-Simon, MD

Prof

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sheba_Medical_Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

References

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Ratnalingam V, Eu AL, Ng GL, Taharin R, John E. Fibrin adhesive is better than sutures in pterygium surgery. Cornea. 2010 May;29(5):485-9. doi: 10.1097/ICO.0b013e3181c29696.

Reference Type RESULT
PMID: 20308876 (View on PubMed)

Por YM, Tan DT. Assessment of fibrin glue in pterygium surgery. Cornea. 2010 Jan;29(1):1-4. doi: 10.1097/ICO.0b013e3181a38fda.

Reference Type RESULT
PMID: 19907303 (View on PubMed)

Hall RC, Logan AJ, Wells AP. Comparison of fibrin glue with sutures for pterygium excision surgery with conjunctival autografts. Clin Exp Ophthalmol. 2009 Aug;37(6):584-9. doi: 10.1111/j.1442-9071.2009.02105.x.

Reference Type RESULT
PMID: 19702708 (View on PubMed)

Other Identifiers

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SHEBA-09-5033-GB-CTIL

Identifier Type: -

Identifier Source: org_study_id

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