The safety and efficacy of Fibrin sealant Thai Red Cross Society compared with commercial fibrin sealant in pterygium volunteer

Phase 2

• Conditions: Pterygium patients in the Ophthalmology clinic of King Chulalongkorn Memorial Hospital; Pterygium, Fibrin Sealant, conjunctival autograft surgery

• Registration Number: TCTR20240723010
• Lead Sponsor: Health Systems Research Institute (HSRI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-23
• Last Update Posted: 19 August 2024
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1.Primary pterygium grade T1 or T2 with indication for surgical excision
Classification of Pterygium Morphology:
Grade T1 = Atrophic pterygium, episcleral vessels unobscured
Grade T2 = Intermediate pterygium, episcleral vessels partially obscured
Grade T3 = Fleshy pterygium, episcleral vessels totally obscured
2. Voluntary informed consent obtained from the patient who is available to come on follow-up visits as indicated in protocol

Exclusion Criteria

1. Currently on topical medication except artificial tears or lubricant gel
2. Diagnosed with ocular surface disease except pterygium, meibomian gland dysfunction, and dry eyes
3. Contraindicated for pterygium surgery with conjunctival autograft such as glaucoma or pseudopterygium
4. Previous conjunctival surgery such as previous pterygium surgery, strabismus surgery or conjunctival mass excision
5. Indicated to combine pterygium surgery with other procedure such as cataract surgery
6. Indicated to combine pterygium surgery with mitomycin-C
7. Pregnancy
8. Preexisting positive serologic test (HBsAg, anti-HCV, anti-HIV or anti-TP)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
graft attachment at 1week post-pterygium excision Rate of graft attachment

Secondary Outcome Measures

Name	Time	Method
Surgical-related complications including: graft loss, infection (keratitis/conjunctivitis/scleritis), excessive ocular surface inflammation, recurrent pterygium within postoperative 3 months Slit lamp photography,Operative time and intraoperative graft attachment time after pterygium excision time count,Pain at surgical area Day 1 post operation numerical pain score ,Surgeon rated satisfaction at the end of the operation Surgeon rated satisfaction score,Satisfaction by assessor Month 1 post operation Satisfaction score by assessor via photo