Pterygium Pterygium Fibrin glue fibrin sealant safety efficacy tissue adhesive
Conditions
Interventions
Apply the first component of the fibrin sealant onto the white part of the eye surface and record the time. Then, follow it by applying the second fibrin sealant drop.
Experimental Drug
Fibrin sealant of National Blood Centre
Sponsors
National Blood Centre, Thai Red Cross Society
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with primary pterygium graded as T1 or T2 for the first time, and who exhibit indications for surgery, such as pterygium causing visual impairment, eye irritation, or significant redness and inflammation; pterygium not responding to medication; minimal complications or scarring from previous pterygium excisions; and pterygium affecting the appearance or quality of life of the patient. 2. Patients aged 18 years or older. 3. Patients who consent to participate in the research and surgery and are able to follow up on treatment outcomes.
Exclusion criteria
Exclusion criteria: 1. Use of eye drops other than artificial tears or artificial tear gel. 2. Presence of other ocular surface diseases excluding meibomian gland dysfunction and dry eye. 3. Contraindications to pterygium excision and conjunctival autografting surgery, such as keratoconus or artificial cornea. 4. History of previous conjunctival autografting surgery. 5. Patients requiring simultaneous pterygium excision with other surgeries (e.g., cataract surgery). 6. Patients with indications for adjunctive chemotherapy (Mitomycin-C) with pterygium excision. 7. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of reinforcement sutures in cases where tissue does not adhere with fibrin glue. 1-2 days post-surgery, 1 week, 1 month, 3 months, and 6 months post-surgery. Ophthalmologists' evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain score upon post-operative follow-up examination 1-2 days post-surgery, 1 week, 1 month, 3 months, and 6 months post-surgery Ophthalmologists' evaluation,Uncorrected distance visual acuity (UCVA) and best corrected distance visual acuity (BCVA). 1-2 days post-surgery, 1 week, 1 month, 3 months, and 6 months post-surgery Ophthalmologists' evaluation,Complications such as graft loss, dehiscence, granuloma, infection, ocular surface inflammation, anterior chamber reaction, and allergic reaction. 1-2 days post-surgery, 1 week, 1 month, 3 months, and 6 months post-surgery Ophthalmologists' evaluation,Duration of surgery (minutes). 1-2 days post-surgery, 1 week, 1 month, 3 months, and 6 months post-surgery Ophthalmologists' evaluation,Time taken to attach conjunctival tissue (seconds). 1-2 days post-surgery, 1 week, 1 month, 3 months, and 6 months post-surgery Ophthalmologists' evaluation,Rate of disease recurrence within 6 months post-surgery. 1-2 days post-surgery, 1 week, 1 month, 3 months, and 6 months post-surgery Ophthalmologists' evaluation,Physician satisfaction score regarding ease of use and tissue attachment. 1-2 days post-surgery, 1 week, 1 month, 3 months, and 6 months post-surgery Ophthalmologists' evaluation,Physician satisfaction score regarding post-operative appearance based on photographs taken during the 1-month follow-up without patient identification. 1-2 days post-surgery, 1 week, 1 month, 3 months, and 6 months post-surgery Ophthalmologists' evaluation,Size of the conjunctival tissue graft. 1-2 days post-surgery, 1 week, 1 month, 3 months, and 6 months post-surgery Ophthalmologists' evaluation | — |
Countries
Thailand
Contacts
Public ContactVilavun Puangsricharern
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed