Pterygium
Conditions
Brief summary
Pterygium is wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that can spread to the corneal limbus and beyond The surgical exeresis with autologous conjunctival autograft technique is the treatment of choice. Commercially available fibrin glue has been used preferentially for graft fixation due to its benefits compared to sutures; However, its cost and the risk of inflammatory immune reaction limit the its use. There are few studies about autologous fibrin glue. OBJECTIVE: To determine the efficacy of autologous fibrin glue preparation in patients undergoing pterygium resection surgery. To compare with autologous conjunctival graft fixation with suture. This is a randomized clinical trial. Two patient groups will undergo pterygium excision surgery. Group 1 will have autologous conjunctival graft fixation with autologous fibrin glue and group 2 will have suture graft fixation using 10.0 mononylon. Early and late postoperative surgical results as well as complication rates will be analyzed.
Interventions
Conjunctival graft fixation with autologous fibrin glue
OTHERSuture
Graft fixation using 10.0 mononylon
Sponsors
Irmandade Santa Casa de Misericórdia de Porto Alegre
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* nasal primary pterygium
Exclusion criteria
* relapsed pterygium * patients with a history of previous eye surgery * patients with glaucoma using hypotensive eye drops * eye surface diseases * eye allergy * diabetic patients,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pterygium Recurrence | 6 months | Recurrence in 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Autograft Retraction | Postoperative day 1, 7, 21 and 30 | Graft detachment or retraction |
| Postoperative Pain | Postoperative day 1, 7, 21 and 30 | Presence Pain measured by a five-point scale, in which 0 means absence of symptom; 1 means easily tolerable symptom; 2 means symptom causing some discomfort; 3 means symptom partially interfering with usual activities and 4 means symptom completely interfering with usual activities |
| Graft Edema | Postoperative day 1, 7, 21 and 30 | Graft edema (1-4). |
Countries
Brazil
Outcome results
None listed