Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye Surgery

NCT00344201 | Completed Phase 1 DMC

• 1 other identifier: R389/47/2004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Tisseel fibrin adhesive has been used extensively in many forms of surgery. Its use in eye surgery has been relatively recent. A few studies recently showed it was effective in securing conjunctival grafts in pterygium surgery, and in securing wounds after glaucoma and squint surgery. We sought to confirm its effectiveness in pterygium surgery, as well as prove its effectiveness in securing other material to the ocular surface such as amniotic membrane. Our hypothesis is that fibrin adhesive is effective in securing various types of material to the ocular surface for a sufficient length of time to allow adequate healing before it is absorbed and degraded.

Conditions

Pterygium; Ocular Surface Cicatrizing Diseases

Keywords

Pterygium; Fibrin adhesive; Conjunctival graft; Ocular surface reconstruction

Outcome Measures

Primary Outcomes (2)

• Graft dislocation

  3 months

• Pterygium recurrence

  6 months

Secondary Outcomes (3)

• Graft dimensions

  6 months

• Patient comfort on visual analogue scale

  1 month

• Visual acuity

  6 months

Interventions

Tisseel fibrin adhesive DEVICE

Intraoperative application to scleral bed and graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• significant pterygium clinically requiring excision
• willingness to participate in research project and to attend research clinic

You may not qualify if:

• age \< 18 years
• other concurrent corneal pathology
• poor acuity due to other ocular pathology
• poor general health

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• National University of Singapore: collaborator

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

Related Publications (5)

• Tan DT, Chee SP, Dear KB, Lim AS. Effect of pterygium morphology on pterygium recurrence in a controlled trial comparing conjunctival autografting with bare sclera excision. Arch Ophthalmol. 1997 Oct;115(10):1235-40. doi: 10.1001/archopht.1997.01100160405001.

  PMID: 9338666 BACKGROUND

• Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4. doi: 10.1136/bjo.2003.032854.

  PMID: 15205236 BACKGROUND

• Cohen RA, McDonald MB. Fixation of conjunctival autografts with an organic tissue adhesive. Arch Ophthalmol. 1993 Sep;111(9):1167-8. doi: 10.1001/archopht.1993.01090090017006. No abstract available.

  PMID: 8363455 BACKGROUND

• Biedner B, Rosenthal G. Conjunctival closure in strabismus surgery: Vicryl versus fibrin glue. Ophthalmic Surg Lasers. 1996 Nov;27(11):967.

  PMID: 8938809 BACKGROUND

• Schlag G , Redl H. Fibrin Sealant in Operative Medicine. Vol 2.Ophthalmology, neurosurgery. Berlin, Heidelberg: Springer Verlag, 1986.

  BACKGROUND

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Officials

• Donald TH Tan, FRCOphth

  Singapore Eye Research Institute

  PRINCIPAL INVESTIGATOR

• Yong M Por, FRCS

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 26, 2006
• Study Start: November 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2008
• Last Updated: May 12, 2010

Record last verified: 2010-05

Locations

SG (1)