Efficacy of Autologous Fibrin Glue in Pterygium

Not Applicable

Completed

• Conditions: Pterygium
• Interventions: Other: Suture; Other: Autologous fibrin glue

• Registration Number: NCT04151017
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-12
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-11-02
• Study First Posted: 2019-11-05
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sutures	Suture	-
Autologous fibrin glue	Autologous fibrin glue	-

Primary Outcome Measures

Name	Time	Method
Pterygium Recurrence	6 months	Recurrence in 6 months

Secondary Outcome Measures

Name	Time	Method
Graft Edema	Postoperative day 1, 7, 21 and 30	Graft edema (1-4).
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
Autograft Retraction	Postoperative day 1, 7, 21 and 30	Graft detachment or retraction

Trial Locations

Locations (1)

Santa Casa de Misericórdia; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil