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OpenTrials
Completed

NCT Number: NCT01024257

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gustavo Viani Arruda

Marília, Saop Paulo, 17516660, Brazil

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

beta-irradiation

Radiation

Conjunctival Autograft

Procedure

Sponsors and collaborators

Lead sponsor

Marilia Medicine School

Other

Registry information

Important dates

First posted
Dec 2, 2009
Registry last updated
Dec 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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