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Treatment of Primary Type I Pterygia With Argon Laser

Primary Purpose

Pterygium

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Sham
Argon Laser Treatment
Sponsored by
Instituto de Oftalmología Fundación Conde de Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto de Oftalmología

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham of Argon Laser Treatment

Argon Laser Treatment

Arm Description

Slit lamp light exposure

Argon Laser Treatment

Outcomes

Primary Outcome Measures

Pterygia measurements
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.

Secondary Outcome Measures

Full Information

First Posted
December 28, 2016
Last Updated
March 26, 2018
Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
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1. Study Identification

Unique Protocol Identification Number
NCT03485001
Brief Title
Treatment of Primary Type I Pterygia With Argon Laser
Official Title
Treatment of Primary Type I Pterygia With Argon Laser
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana

4. Oversight

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham of Argon Laser Treatment
Arm Type
Sham Comparator
Arm Description
Slit lamp light exposure
Arm Title
Argon Laser Treatment
Arm Type
Experimental
Arm Description
Argon Laser Treatment
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
This group will not receive argon laser medical treatment; instead, they will be only exposed to the slit lamp light.
Intervention Type
Procedure
Intervention Name(s)
Argon Laser Treatment
Intervention Description
This group will receive argon laser medical treatment to the body and head of pterygium
Primary Outcome Measure Information:
Title
Pterygia measurements
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto de Oftalmología
City
Mexico City
ZIP/Postal Code
06800
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
21505540
Citation
Welch MN, Reilly CD, Kalwerisky K, Johnson A, Waller SG. Pterygia measurements are more accurate with anterior segment optical coherence tomography - a pilot study. Nepal J Ophthalmol. 2011 Jan-Jun;3(1):9-12. doi: 10.3126/nepjoph.v3i1.4271.
Results Reference
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PubMed Identifier
12502940
Citation
Nava-Castaneda A, Tovilla-Canales JL, Rodriguez L, Tovilla Y Pomar JL, Jones CE. Effects of lacrimal occlusion with collagen and silicone plugs on patients with conjunctivitis associated with dry eye. Cornea. 2003 Jan;22(1):10-4. doi: 10.1097/00003226-200301000-00003.
Results Reference
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Treatment of Primary Type I Pterygia With Argon Laser

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