Efficacy of Autologous Fibrin Glue in Pterygium

Pterygium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151017
• Other study ID #: 20170467
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2022
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

• Pterygium

Intervention

Other:
• Autologous fibrin glue
Conjunctival graft fixation with autologous fibrin glue
• Suture
Graft fixation using 10.0 mononylon

Locations

Country	Name	City	State
Brazil	Santa Casa de Misericórdia	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Irmandade Santa Casa de Misericórdia de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pterygium Recurrence	Recurrence in 6 months	6 months
Secondary	Autograft Retraction	Graft detachment or retraction	Postoperative day 1, 7, 21 and 30
Secondary	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
Secondary	Graft Edema	Graft edema (1-4).	Postoperative day 1, 7, 21 and 30