Efficacy of Autologous Fibrin Glue in Pterygium

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Pterygium

Treatments: Other: Suture; Other: Autologous fibrin glue

Study type: Interventional

Funder types: Other

Identifiers

NCT04151017

20170467

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Autologous fibrin glue

Experimental group

Treatment:

Other: Autologous fibrin glue

Sutures

Active Comparator group

Treatment:

Other: Suture