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
About this trial
This is an interventional trial for Pterygium focused on measuring beta-irradiation;conjunctival autograft;pterygium;recurrence; clinical trial
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.
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
NCT ID
NCT01024257
First Posted
November 30, 2009
Last Updated
December 1, 2009
Sponsor
Marilia Medicine School
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
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Primary Completion Date
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Study Completion Date
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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
Learn more about this trial
Pterygium Treatment Using Single Beta-therapy as Adjuvant Treatment Compared to Conjunctival Autograft
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