ClinicalTrials.gg
CompletedNCT04151017Updated Mar 14, 2022

Efficacy of Autologous Fibrin Glue in Pterygium

An interventional study of Autologous fibrin glue and Suture in Pterygium, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-14.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2019, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pterygium

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03

In context

Pterygium

109 studies on the registry are indexed under Pterygium; 9 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 93 interventional studies indexed under Pterygium.

Browse Pterygium studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • nasal primary pterygium

Exclusion criteria

Exclusion Criteria:

  • pterygium
  • patients with a history of previous eye surgery
  • patients with glaucoma using hypotensive eye drops
  • eye surface diseases
  • eye allergy
  • diabetic patients,
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Autologous fibrin glue

    Other: Autologous fibrin glue

  • Active comparator
    Sutures

    Other: Suture

Interventions

  • OtherAutologous fibrin glue

    Conjunctival graft fixation with autologous fibrin glue

  • OtherSuture

    Graft fixation using 10.0 mononylon

06

What researchers measure

Primary outcomes

  1. Pterygium Recurrence

    Recurrence in 6 months

    Time frame: 6 months

Secondary outcomes

  1. Autograft Retraction

    Graft detachment or retraction

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

  2. 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

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

  3. Graft Edema

    Graft edema (1-4).

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

07

Study locations

1 site
  • Santa Casa de Misericórdia
    Porto Alegre, Rio Grande Do Sul, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04151017
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
Responsible party
Sponsor
First posted
Nov 5, 2019
Start date
Jun 12, 2019
Primary completion
Dec 1, 2020
Completion
Dec 1, 2020
Last update
Mar 14, 2022

Study contacts

Diane Marinho
principal investigator · Hospital de Clinicas de Porto Alegre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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