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Pterygium Treatment Using Single Beta-therapy as Adjuvant Treatment Compared to Conjunctival Autograft

Primary Purpose

Pterygium

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
beta-irradiation
conjunctival autograft
Sponsored by
Marilia Medicine School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Pterygium focused on measuring beta-irradiation;conjunctival autograft;pterygium;recurrence; clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Fresh pterygium without previous treatment.
  • Adult patients with age higher than 18 years.

Exclusion Criteria:

  • Diagnosis of glaucoma.
  • Previous treatment of pterygium.
  • Patients with age less than 18 years old.

Sites / Locations

  • Gustavo Viani Arruda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

conjunctival autograft plus beta-irradiation

conjunctival autograft

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 30, 2009
Last Updated
December 1, 2009
Sponsor
Marilia Medicine School
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1. Study Identification

Unique Protocol Identification Number
NCT01024257
Brief Title
Pterygium Treatment Using Single Beta-therapy as Adjuvant Treatment Compared to Conjunctival Autograft
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Marilia Medicine School

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
PURPOSE: To affirm the effectiveness and complication rate of postoperative single-dose beta-irradiation (RT) with (90) Sr in the case of primary pterygium in a clinical trial. METHODS AND MATERIALS: This trial was designed as a prospective, randomized, single center study. Surgery was performed in all cases according to the conjunctival autograft technique. One thousand and four patients with 108 pterygia were postoperatively randomized to either beta-RT or observation. In the case of beta-RT, a (90) Sr eye applicator was used to deliver 1000 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. RESULTS: Between February 2007 and September 2008, 104 eyes with primary pterygium were operated on according to the trial protocol. Additional treatment was performed within 24 hours postoperatively. Four patients were lost to follow-up, resulting in 104 patients who could be analyzed. In the 54 eyes randomized to receive beta-RT, 5 relapses occurred compared with 8 recurrences in the 50 eyes that no received RT, for a crude control rate of 90.7 % vs. 84 %, respectively. At a mean follow-up of 9 months (range 4- 18), major treatment complications had not been observed . CONCLUSION: Single-dose beta-RT of 1000cGy after conjunctival autograft surgery is a simple, effective, and safe treatment that reduces the risk of primary pterygium recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
beta-irradiation;conjunctival autograft;pterygium;recurrence; clinical trial

7. Study Design

Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
conjunctival autograft plus beta-irradiation
Arm Type
Experimental
Arm Title
conjunctival autograft
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
beta-irradiation
Intervention Type
Procedure
Intervention Name(s)
conjunctival autograft

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Fresh pterygium without previous treatment. Adult patients with age higher than 18 years. Exclusion Criteria: Diagnosis of glaucoma. Previous treatment of pterygium. Patients with age less than 18 years old.
Facility Information:
Facility Name
Gustavo Viani Arruda
City
Marilia
State/Province
Saop Paulo
ZIP/Postal Code
17516660
Country
Brazil

12. IPD Sharing Statement

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Pterygium Treatment Using Single Beta-therapy as Adjuvant Treatment Compared to Conjunctival Autograft

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