Efficacy of Autologous Fibrin Glue in Pterygium

Study Overview
=================
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.

Official Title
-----------------
Efficacy of Autologous Fibrin Glue Versus Suture for Conjuntival Autografting in Primary Pterygium Surgery: a Randomized Clinical Trials

Conditions
-----------------
Pterygium

Intervention / Treatment
-----------------
* Other: Autologous fibrin glue
* Other: Suture


Participation Criteria
=================
Eligibility Criteria
-----------------
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,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous fibrin glue<br> | Other: Autologous fibrin glue<br>* Conjunctival graft fixation with autologous fibrin glue<br>|
| Active Comparator: Sutures<br> | Other: Suture<br>* Graft fixation using 10.0 mononylon<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pterygium Recurrence | Recurrence in 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autograft Retraction | Graft detachment or retraction | Postoperative day 1, 7, 21 and 30 | 
| Postoperative Pain | 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 | Postoperative day 1, 7, 21 and 30 | 
| Graft Edema | Graft edema (1-4). | Postoperative day 1, 7, 21 and 30 |