Efficacy of Autologous Fibrin Glue in Pterygium

NCT ID: NCT04151017

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2020-12-01

Brief Summary

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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

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Conditions

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Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Autologous fibrin glue

Group Type EXPERIMENTAL

Autologous fibrin glue

Intervention Type OTHER

Conjunctival graft fixation with autologous fibrin glue

Sutures

Group Type ACTIVE_COMPARATOR

Suture

Intervention Type OTHER

Graft fixation using 10.0 mononylon

Interventions

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Autologous fibrin glue

Conjunctival graft fixation with autologous fibrin glue

Intervention Type OTHER

Suture

Graft fixation using 10.0 mononylon

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Irmandade Santa Casa de Misericórdia de Porto Alegre

OTHER

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diane Marinho

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

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Santa Casa de Misericórdia

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Cioba C, Marafon SB, Fortes BGB, Cavalheiro MT, Fabris M, Michel G, Zambon GM, Marcon A, Marinho DR. Autologous fibrin glue versus sutures for conjunctival autograft in primary pterygium: a randomized clinical trial. Int Ophthalmol. 2023 Jul;43(7):2371-2381. doi: 10.1007/s10792-023-02635-z. Epub 2023 Jan 18.

Reference Type DERIVED
PMID: 36652022 (View on PubMed)

Other Identifiers

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20170467

Identifier Type: -

Identifier Source: org_study_id

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