Pterygium patients in the Ophthalmology clinic of King Chulalongkorn Memorial Hospital Pterygium, Fibrin Sealant, conjunctival autograft surgery
Conditions
Interventions
IP name : Fibrin sealant TRCS
Drug substance :
1. Sealer protein solution: Human fibrinogen 60 mg/ML
2. Thrombin solution: Human thrombin 500 IU/ML
Pharmaceutical form : Solution
Appearance: Colo
Experimental Drug,Active Comparator Drug
Sponsors
Health Systems Research Institute (HSRI)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| graft attachment at 1week post-pterygium excision Rate of graft attachment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactAsst. Prof. Vilavun Puangsricharern
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed