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AIM: To evaluate the effect of femtosecond laser-assisted lens surgery (FLALS; cataract surgery or refractive lens exchange) on the structure of the optic nerve head and the macula. METHODS: This prospective longitudinal study included healthy eyes undergoing FLALS. Eyes with glaucoma or any other ocular disease that could alter optical coherence tomography results were excluded. Retinal nerve fiber layer (RNFL), Bruch's membrane opening-minimum rim width (BMO-MRW) and macular thickness (MT) were measured preoperatively, 1 and 6mo after surgery using spectral-domain optical coherence tomography (SD-OCT). Changes between preoperative and postoperative values were evaluated. RESULTS: A total of 87 eyes of 46 patients were included in this study. Preoperative RNFL, BMO-MRW and MT in microns (µm) were 100.77±10.39, 330.31±49.99 and 276.30±33.39, respectively. Postoperative RNFL, BMO-MRW and MT were 104.74±11.55, 348.32±54.05 and 279.83±22.65 1mo after surgery and 102.93±11.17, 343.11±53.4 and 278.90±22.19 6mo after surgery, respectively; which equals an increase of 3.93%, 5.45% and 1.27%, respectively, 1mo after surgery, and 2.14%, 3.87% and 0.94% 6mo after surgery. The differences between the preoperative and the postoperative RNFL and BMO-MRW values were statistically significant (P<0.001). Regarding MT values, there were not statistically significant differences (P=0.26). CONCLUSION: Our study suggests that FLALS does not have a negative impact on the structural status of the optic nerve head in healthy eyes, assessed by SD-OCT. There is a slight increase in the values of RNFL, BMO-MRW and MT 1mo and 6mo after surgery.
RESUMO
PURPOSE: To compare efficacy, safety, and tolerability of the preservative-free fixed combination (FC) and non-fixed combination (NFC) of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. METHODS: This 6-month, prospective, randomized, double-masked, active-controlled, parallel group, multicenter phase III study was performed in patients with ocular hypertension and open-angle glaucoma with untreated intraocular pressure (IOP) ≥23 and ≤36 mmHg at baseline. RESULTS: Four hundred patients washed out from IOP-lowering medication were randomized, 201 received the FC, and 199 received the NFC. Mean time-wise IOP decreases from baseline ranged from -7.3 to -9.1 mmHg (29.6%-34.6%) in the FC and from -7.5 to -9.4 mmHg (30.7%-36.0%) in the NFC arm [per-protocol (PP) dataset, P<0.0001 compared with baseline for both groups]. At month 6, the estimated overall treatment difference (FC-NFC) was 0.308 mmHg (PP dataset, 95% confidence interval from -0.194 to 0.810 mmHg). An IOP decrease ≥30% was achieved in 58.3% and 66.9% of the patients in the FC and NFC groups, respectively (PP dataset; P=0.105); an IOP decrease ≥35% was achieved in 36.6% and 43.1% of patients in the FC and NFC groups, respectively (PP dataset; P=0.297). Patients with ocular adverse events were evenly distributed in both groups. The most common side effect, conjunctival/ocular hyperemia was found in 8% and 5% of patients in the FC and NFC arms, respectively. CONCLUSIONS: All measures of IOP reduction for FC of preservative-free tafluprost/timolol were statistically and clinically significant and non-inferior to those of the NFC, throughout the 6-month study period.
