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Efficacy of Autologous Fibrin Glue in Pterygium

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Completed
CT.gov ID
NCT04151017
Collaborator
Irmandade Santa Casa de Misericórdia de Porto Alegre (Other)
64
Enrollment
1
Location
2
Arms
17.7
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Autologous fibrin glue
  • Other: Suture
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Autologous Fibrin Glue Versus Suture for Conjuntival Autografting in Primary Pterygium Surgery: a Randomized Clinical Trials
Actual Study Start Date :
Jun 12, 2019
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Autologous fibrin glue

Other: Autologous fibrin glue
Conjunctival graft fixation with autologous fibrin glue
Active Comparator: Sutures

Other: Suture
Graft fixation using 10.0 mononylon

Outcome Measures

Primary Outcome Measures

  1. Pterygium Recurrence [6 months]

    Recurrence in 6 months

Secondary Outcome Measures

  1. Autograft Retraction [Postoperative day 1, 7, 21 and 30]

    Graft detachment or retraction

  2. 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

  3. Graft Edema [Postoperative day 1, 7, 21 and 30]

    Graft edema (1-4).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Santa Casa de Misericórdia Porto Alegre Rio Grande Do Sul Brazil

Sponsors and Collaborators

  • Hospital de Clinicas de Porto Alegre
  • Irmandade Santa Casa de Misericórdia de Porto Alegre

Investigators

  • Principal Investigator: Diane Marinho, Hospital de Clinicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT04151017
Other Study ID Numbers:
  • 20170467
First Posted:
Nov 5, 2019
Last Update Posted:
Mar 14, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pterygium
Fibrin Tissue Adhesive

Study Results

No Results Posted as of Mar 14, 2022