Abstract
Purpose: :
To affirm the effectiveness and complication rate of postoperative low single-dose of beta-irradiation (RT) with (90) Sr in the case of primary pterygium in a clinical trial.
Methods: :
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. This trial is registered in the ClinicalTrials.gov with the identifier number NTC01024257.
Results: :
Between February 2008 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. At a mean follow-up of 9 months (range 4- 18), 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. The treatment complications as hyperemia, total dehiscence of the autograft and dellen were significantly more frequent in the arm of observation (p<0.05).
Conclusions: :
Low single-dose of beta-RT of 1000cGy after conjunctival autograft surgery is a simple, effective, and safe treatment that reduces the risk of primary pterygium recurrence.
Clinical Trial: :
www.clinicaltrials.gov NTC01024257
Keywords: pterygium • radiation therapy • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials