The Efficacy and Safety of Pneumotrabeculoplasty : Results of a 6-Month, Multicenter Study

Purpose: To evaluate the efficacy and safety of pneumotrabeculoplasty (PNT) in ocular hypertensive (OHT) and glaucoma (POAG) patients. Methods: This study included 35 patients of 4 Italian academic centers with diagnosis of OHT or POAG and intraocular pressure (IOP) ranging between 20 and 25 mmHg under treatment. Exclusion criteria were: severe glaucoma (mean defect worse than 12 dB), past intraocular surgery or inflammation, corneal or conjunctival abnormalities, any retinopathy. Patients underwent screening (-1 day) and baseline visits (day 0) and visits at days 1, 7, 8, 14, 30, 60, 90, 120, 150, 180; PNT was performed in a randomized eye at day 0 and 7. Safety was addressed at all visits by means of ophthalmic examination and questionnaire; an IOP curve (at 8 and 10 am, noon and 2 pm) was measured at days -1, 60, 120, 180. Results: In PNT-eyes, IOP at day 0 was 19.9 \ub1 2.8 mmHg; after PNT, a statistically significant reduction of IOP occurred at all visits. At days 60, 120, 180, IOP was 17.7 \ub1 5.2, 18.6 \ub1 3.9 and 18.9 \ub1 1.3 mmHg (P = 0.001; 0.005; 0.009 respectively). The rate of non-responder (IOP decrease < 5%) to PNT at 6 months was 9/35 (25%) and the mean IOP decrease was 13.8 \ub1 7.5%. Side effects occurred in 21/35 (60%) patients and included: foreign body sensation (16/35), conjunctival hyperaemia (9), blurred vision (8). All symptoms were mild, with a mean duration of 2 days (range: 30 minutes - 14 days). Conclusion: In this small group of patients, PNT treatment reduced IOP of about 14% over a 6-month interval. Mild side effects were common (60%), but no serious side effects occurred. PNT seems an effective and safe procedure for treatment of glaucoma and ocular hypertension, although confirmation by studies with longer follow-up and larger sample size is mandatory