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Fibrin Glue vs. Suture in Pterygium Surgery

Primary Purpose

Conjunctival Autograft

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Fibrin Glue, Quixil

Suture

About this trial

This is an interventional treatment trial for Conjunctival Autograft focused on measuring pterygium, conjunctival graft, recurrence, primary pterygium

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sheba_Medical_Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fibrin Glue, surgery

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pterygium recurrence

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

Secondary Outcome Measures

operation time

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

Full Information

NCT ID

NCT01158014

First Posted

July 4, 2010

Last Updated

August 7, 2017

Sponsor

Dr. Guy Ben-Simon, MD

1. Study Identification

Unique Protocol Identification Number

NCT01158014

Brief Title

Fibrin Glue vs. Suture in Pterygium Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

January 2014 (Actual)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Guy Ben-Simon, MD

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Conjunctival Autograft

Keywords

pterygium, conjunctival graft, recurrence, primary pterygium

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fibrin Glue, surgery

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Fibrin Glue, Quixil

Intervention Description

quixil 0.1 ml

Intervention Type

Procedure

Intervention Name(s)

Suture

Intervention Description

vicryl 10/0

Primary Outcome Measure Information:

Title

Pterygium recurrence

Description

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

Time Frame

one year

Secondary Outcome Measure Information:

Title

operation time

Description

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

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Sheba_Medical_Center

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

20308876

Citation

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.

Results Reference

result

PubMed Identifier

19907303

Citation

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

Results Reference

result

PubMed Identifier

19702708

Citation

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.

Results Reference

result

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Fibrin Glue vs. Suture in Pterygium Surgery

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