title: Pilot study to evaluate the efficacy and safety of pneumatic trabeculoplasty in glaucoma and ocular hypertension.
abstract: OBJECTIVE
  Following laser-assisted in situ keratomileusis (LASIK), intraocular pressure (IOP) is measurably lower in a significant number of cases. It has been proposed that the decrease in IOP may be a real event. Prior trials have evaluated pneumatic trabeculoplasty (PNT) in combination with concomitant glaucoma medications. The aim of this study was to determine the efficacy and the safety of PNT alone to lower IOP in patients with primary open angle glaucoma (POAG) or ocular hypertension (OH).
  
  
  RESULTS
  A total of 37 subjects with POAG or OH were enrolled in a prospective, open-label, fellow-eye, multicenter trial to determine the IOP lowering effects of PNT. All subjects underwent ophthalmologic examinations and IOP measurements and were washed out from all glaucoma medications prior to the start of the study. The trial was intrapatient controlled for the first 30 days, with one eye receiving PNT at days 0 and 7 and the fellow eye serving as the control. The second eye was treated with PNT at day 30. The patients were followed for 120 days, with the first eye receiving an additional PNT treatment at days 90 and 97. Two analyses-an intent to treat analysis in which the last IOP measurement for patients dropped from the study was carried forward and an analysis including only those patients who completed the trial-were performed. Of the 37 patients enrolled, 27 (73%) completed the study. For the intent to treat analysis the baseline mean IOP was 24.7+/-1.9 mmHg for eye 1 and 23.6+/-2.3 mmHg for eye 2 and the difference was statistically significant (p<0.05). Using this analysis the differences between eye 1 mean IOP at days 1, 7, 14, and 60 and the baseline mean IOP were statistically significant (p<0.05). The differences between eye 2 mean IOP and the baseline mean IOP were statistically significant (p<0.05) at all time points except day 14 and day 30. The greater mean IOP reductions from the baseline mean IOP for eye 1 were at study day 1 (-16,1%), day 14 (-9%), and day 60 (-8.9%). For eye 2 they were at day 60 (-8.7%) and at day 120 (-9.1%). For the analysis that included only those subjects who completed the trial the decrease in eye 1 mean IOP from baseline was statistically significant (p<0.05) at all time points. The decrease in eye 2 mean IOP from baseline was statistically significant at all time points except day 30. Using this analysis the greater mean IOP reductions from the baseline mean IOP for eye 1 were at study day 1 (-19%), day 14 (-15.7%), day 37 (-16.3%), day 60 (-20.0%), day 90 (-18.1%), day 97 (-16.8%), and day 120 (-15.8%). For eye 2 greater mean IOP reductions from baseline mean IOP were seen on day 37 (-13.0%), day 60 (-16.7%), day 90 (-15.5%), day 97 (-14.5%), and day 120 (-7.2%). No statistically significant differences were found in mean IOP reduction between the two eyes treated. A total of 34 patients (92%) showed adverse effects: conjunctival hyperemia in 26 (70.3%) and conjunctival hemorrhage in 14 (37.8%).
  
  
  CONCLUSIONS
  This pilot study of PNT showed a potentially good IOP lowering effect on glaucoma and hypertensive patients. Additional studies would help to better define the types of patients who respond to PNT and to identify risk factors that may lead to treatment failure.
authors.affiliation: Department of Ophthalmology, "Tor Vergata" University of Roma, G.B. Bietti Foundation for Ophthalmology, ONLUS, Roma, Italy.
authors.forename: M G
authors.initials: MG
authors.lastname: Bucci
authors.forename: M
authors.initials: M
authors.lastname: Centofanti
authors.forename: F
authors.initials: F
authors.lastname: Oddone
authors.forename: M
authors.initials: M
authors.lastname: Parravano
authors.forename: C
authors.initials: C
authors.lastname: Balacco Gabrieli
authors.forename: J
authors.initials: J
authors.lastname: Pecori-Giraldi
authors.forename: A
authors.initials: A
authors.lastname: Librando
authors.forename: E
authors.initials: E
authors.lastname: Paone
authors.forename: L D
authors.initials: LD
authors.lastname: Bores
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000601:surgery; D010865:Pilot Projects; D011446:Prospective Studies; D012449:Safety; D014130:Trabeculectomy / Q000379:methods*; D016896:Treatment Outcome