PURPOSE: To describe and compare long-term (> or = 36 months) effects of patients with 86 primary pterygia treated withbare sclera extirpation (BSE) followed by Beta-RT or by sham irradiation. METHODS: Prospective, multicenter, randomized, double-blind study. After BSE of their pterygium, patients were randomized to either Beta-RT or sham irradiation. In the case of Beta-RT, within 24 hours after the operation, a 90Sr eye applicator was used to deliver 2500 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. Sham irradiation was given using the same type of applicator without the 90Sr layer. After treatment, both a masked ophthalmologist and a radiation oncologist performed follow-up examinations. These were continued until either a relapse occurred or at least 36 months had elapsed. RESULTS: Adequate follow-up was available of 86 pterygia in 81 patients, treated between February 1998 and September 2002. Fifty-two (60%) patients were male. The mean age of the patients was 50 years (range: 24-77). After a follow-up of at least 36 months (mean: 40 months, SD:13.9 months), 5 out of 44 eyes (11%) treated with Beta-RT showed a recurrence versus 32 out of 42 eyes (76%) treated with sham-RT (after a mean follow-up of 22 months) (p<0.001). In the Beta-RT group, 80% were satisfied with the cosmetic result, whereas in the sham group this percentage was 41% (p<0.001). In the Beta-RT group, no scar or a white scar could be detected in 86% of the treated eyes, versus in 24% of the sham irradiated eyes (p<0.001). A change of keratometry (Javal) was seen in 5 patients (12%) following Beta-RT compared to 16 (38%) after sham irradiation (p=0.002). Complications were few: a granuloma was seen in three patients after sham irradiation, mild limitation of abduction in two Beta-RT patients versus in five after sham irradiation, and mild scleromalacia in one Beta-RT patient. CONCLUSIONS: Bare sclera extirpation of a pterygium without adjuvant treatment has an unacceptably high recurrence rate and therefore should be considered obsolete. Bare sclera extirpation of a primary pterygium followed by a single-dose Beta-RT is a simple, effective, and safe treatment with lasting results and very few complications.
RCT Entities:
PURPOSE: To describe and compare long-term (> or = 36 months) effects of patients with 86 primary pterygia treated with bare sclera extirpation (BSE) followed by Beta-RT or by sham irradiation. METHODS: Prospective, multicenter, randomized, double-blind study. After BSE of their pterygium, patients were randomized to either Beta-RT or sham irradiation. In the case of Beta-RT, within 24 hours after the operation, a 90Sr eye applicator was used to deliver 2500 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. Sham irradiation was given using the same type of applicator without the 90Sr layer. After treatment, both a masked ophthalmologist and a radiation oncologist performed follow-up examinations. These were continued until either a relapse occurred or at least 36 months had elapsed. RESULTS: Adequate follow-up was available of 86 pterygia in 81 patients, treated between February 1998 and September 2002. Fifty-two (60%) patients were male. The mean age of the patients was 50 years (range: 24-77). After a follow-up of at least 36 months (mean: 40 months, SD:13.9 months), 5 out of 44 eyes (11%) treated with Beta-RT showed a recurrence versus 32 out of 42 eyes (76%) treated with sham-RT (after a mean follow-up of 22 months) (p<0.001). In the Beta-RT group, 80% were satisfied with the cosmetic result, whereas in the sham group this percentage was 41% (p<0.001). In the Beta-RT group, no scar or a white scar could be detected in 86% of the treated eyes, versus in 24% of the sham irradiated eyes (p<0.001). A change of keratometry (Javal) was seen in 5 patients (12%) following Beta-RT compared to 16 (38%) after sham irradiation (p=0.002). Complications were few: a granuloma was seen in three patients after sham irradiation, mild limitation of abduction in two Beta-RTpatients versus in five after sham irradiation, and mild scleromalacia in one Beta-RTpatient. CONCLUSIONS: Bare sclera extirpation of a pterygium without adjuvant treatment has an unacceptably high recurrence rate and therefore should be considered obsolete. Bare sclera extirpation of a primary pterygium followed by a single-dose Beta-RT is a simple, effective, and safe treatment with lasting results and very few complications.
Authors: Jeanie Chui; Minas T Coroneo; Lien T Tat; Roger Crouch; Denis Wakefield; Nick Di Girolamo Journal: Am J Pathol Date: 2011-02 Impact factor: 4.307
Authors: Brian P Marr; David H Abramson; Gil'ad N Cohen; Matthew J Williamson; Beryl McCormick; Christopher A Barker Journal: JAMA Ophthalmol Date: 2015-03 Impact factor: 7.389