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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03485001
Other study ID # CC-08-2011
Secondary ID
Status Completed
Phase N/A
First received December 28, 2016
Last updated March 26, 2018
Start date March 2014
Est. completion date October 2016

Study information

Verified date March 2018
Source Instituto de Oftalmología Fundación Conde de Valenciana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Sham
This group will not receive argon laser medical treatment; instead, they will be only exposed to the slit lamp light.
Procedure:
Argon Laser Treatment
This group will receive argon laser medical treatment to the body and head of pterygium

Locations

Country Name City State
Mexico Instituto de Oftalmología Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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