Treatment of Primary Type I Pterygia With Argon Laser

Not Applicable

Completed

• Conditions: Pterygium
• Interventions: Procedure: Argon Laser Treatment; Other: Sham

• Registration Number: NCT03485001
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary

Introduction: Pterygium is a wing shape degenerative and hyperplastic growth of the bulbar conjunctiva extending onto the cornea, most commonly on the nasal side. Management of pterygium can be medical, surgical or combined. Alternative treatments as photocoagulation of blood vessels of the pterygium, have been described, especially in recurrent pterygia.

Objectives: To determine whether Argon laser treatment reduces the symptoms and pterygium size in primary type I pterygia patients when compared with medical treatment. Subjects and Methods: Prospective, comparative and interventional study. Patients with type I pterygia in both eyes were included. The eyes were randomly divided to receive either Argon laser treatment or only topical medical treatment

Detailed Description

Pterygium is a wing shape degenerative and hyperplastic growth of the bulbar conjunctiva extending onto the cornea, most commonly on the nasal side. Management of pterygium can be medical, surgical or combined. Alternative treatments as photocoagulation of blood vessels of the pterygium, have been described, especially in recurrent pterygia.

To determine whether Argon laser treatment reduces the symptoms and pterygium size in primary type I pterygia patients when compared with medical treatment. Subjects and Methods: Prospective, comparative and interventional study. Patients with type I pterygia in both eyes were included. The eyes were randomly divided to receive either Argon laser treatment or only topical medical treatment

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-12-28
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-26
• Last Update Submitted: 2018-03-26
• Study First Posted: 2018-04-02
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Patients who had had symmetric type I pterygia in both eyes
• Assessments for the 6 month follow-up period after argon laser treatment

Exclusion Criteria

• Patients with diabetes Mellitus, collagenopathies, previous ocular surgeries, and pregnant patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Argon Laser Treatment	Argon Laser Treatment	Argon Laser Treatment
Sham of Argon Laser Treatment	Sham	Slit lamp light exposure

Primary Outcome Measures

Name	Time	Method
Pterygia measurements	1 year	Measurements were performed according to Welch et al. modified technique as following: the distance in millimeters from the limbus to the apex of the lesion on the cornea (horizontal length) was performed using the slit-lamp beam (BQ 900, Haag-Streit, Koeniz, Switzerland). A standard magnification of 16 was used and the variable aperture was focused from the limbus to the apex.

Trial Locations

Locations (1)

Instituto de Oftalmología; 🇲🇽 Mexico City, Mexico