Treatment of Primary Type I Pterygia With Argon Laser

Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana (Other)
Overall Status
Completed
CT.gov ID
NCT03485001
Collaborator
(none)
16
1
2
31
0.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Sham
  • Procedure: Argon Laser Treatment
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Treatment of Primary Type I Pterygia With Argon Laser
Actual Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Sham of Argon Laser Treatment

Slit lamp light exposure

Other: Sham
This group will not receive argon laser medical treatment; instead, they will be only exposed to the slit lamp light.

Experimental: Argon Laser Treatment

Argon Laser Treatment

Procedure: Argon Laser Treatment
This group will receive argon laser medical treatment to the body and head of pterygium

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto de Oftalmología Mexico City Mexico 06800

Sponsors and Collaborators

  • Instituto de Oftalmología Fundación Conde de Valenciana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Instituto de Oftalmología Fundación Conde de Valenciana
ClinicalTrials.gov Identifier:
NCT03485001
Other Study ID Numbers:
  • CC-08-2011
First Posted:
Apr 2, 2018
Last Update Posted:
Apr 2, 2018
Last Verified:
Mar 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 2, 2018