Treatment of Primary Type I Pterygia With Argon Laser

NCT03485001 | Completed

• 1 other identifier: CC-08-2011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Sham of Argon Laser Treatment

SHAM COMPARATOR

Slit lamp light exposure

Other: Sham

Argon Laser Treatment

EXPERIMENTAL

Argon Laser Treatment

Procedure: Argon Laser Treatment

Interventions

Sham OTHER

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

Sham of Argon Laser Treatment

Argon Laser Treatment PROCEDURE

This group will receive argon laser medical treatment to the body and head of pterygium

Argon Laser Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmología

Mexico City, 06800, Mexico

Location

Related Publications (2)

• 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.

  PMID: 21505540 BACKGROUND

• 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.

  PMID: 12502940 BACKGROUND

MeSH Terms

Conditions

Pterygium

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: April 2, 2018
• Study Start: March 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

ME (1)