Skip to main content
OpenTrials
Completed

NCT Number: NCT04151017

Efficacy of Autologous Fibrin Glue in Pterygium

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Casa de Misericórdia

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Autologous fibrin glue

Other

Conjunctival graft fixation with autologous fibrin glue

Suture

Other

Graft fixation using 10.0 mononylon

Primary outcomes

  1. Pterygium Recurrence

    Time frame: 6 months

    Recurrence in 6 months

Secondary outcomes

  1. Autograft Retraction

    Time frame: Postoperative day 1, 7, 21 and 30

    Graft detachment or retraction

  2. Postoperative Pain

    Time frame: 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

  3. Graft Edema

    Time frame: Postoperative day 1, 7, 21 and 30

    Graft edema (1-4).

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2019
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.