Evaluation of Tranilast to Treat Pterygium Before Excision
Condition: Pterygium
MeSH terms: Pterygium
Study type: Interventional
Phase: Phase 3

Summary: 
      Recurrent or secondary pterygium often has often a growing fibrovascular tissue more
      exuberant than the primary. Histological findings differ from the primary, since the typical
      changes in the degenerate connective tissue are absent. The strong immunoreactivity and
      release of basic fibroblast growth (b-FGF) in cultured fibroblasts of recurrent pterygia
      suggest that fibroblasts may play an important role in pterygium recurrence. Tranilast used
      is an antiallergic drug that has an inhibitory effect on the release of chemical
      transmitters, such as histamine and leukotrienes from mast cells as well as a suppressive
      effect on vascular permeability.This drug also reduces TGF-β1 production and collagen
      synthesis in various cells. Tranilast might reduce pterygium recurrence by suppressing TGF-β1
      synthesis in conjunctival fibroblast after pterygium surgery. The investigators want to
      confirm these findings and also compare the recurrence rate between the two types of surgery.
      Tranilast might be an alternative of mitomycin use, and also less toxic. This study aim to
      compare the effectiveness of preventing recurrence by using tranilast by topical
      subconjunctival administration previous to conjunctival autograft transplantation surgery in
      cases of primary pterygium, and will be perform clinical evaluation and TGF-beta-1
      immunohistochemical detection by the anti-TGF-beta 1 antibody as well as fibroblast culture.
    

Detailed description: 
      This is a prospective, randomised, control trial of 50 participants. Twenty five patients in
      each arm. Twenty five patients undergo standard pterygium excision with the fibrin glue
      (Tissucol) conjunctival autograft . Twenty five patients undergo pterygium surgery with
      fibrin glue (Tissucol), and subconjunctival injection of 0.1 ml of Tranilast 1.0% in the head
      of pterygium 30 days before surgery. Participants will be reviewed, selected, and consented
      on a pre-assessment day. Surgery will be performed 4 at a time on an all day surgery
      operating list. Randomisation of the surgery type will be done at the time of surgery after
      the pterygium has been excised and the autograft taken. The surgeries will perform by a
      single surgeon (Almeida Jr, GC). Follow-up will occur at week 1,4, 26, 52. Slit lamp
      examination will indicate pterygium recurrence. Corneal recurrence will consider when it 0.5
      mm of invaded conjunctival tissue,in the clear cornea from the anatomical limbus. The
      conjunctival recurrence will consider of any size conjunctive fibrovascular invasion inside
      the graft. The localization and of immunohistochemical will be perform for TGF-B.
    

Intervention name(s): Tranilast, and Tissucol; Beriplast P
Intervention type(s): Drug; Other
Intervention description(s): 1.0%, 0.1 ml, subconjunctival route, single dose; 0.1 ml to attach graft
Other intervention name(s): Rizaben, Tissucol; Tissucol
Intervention MeSH terms: Tranilast; Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tranilast; fibrin glue; primary pterygium; conjunctival autograft