A new system, the LipiFlow, for the treatment of meibomian gland dysfunction.

PURPOSE: To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress (WC) for adults with meibomian gland dysfunction (MGD). METHODS: This was a non-significant risk, prospective, open-label, randomized, crossover multicenter clinical trial. One hundred thirty-nine subjects were randomized between LipiFlow (n=69) and WC control (n=70). Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks. At 2 weeks, they crossed over (LipiFlow Crossover) and received the LipiFlow treatment. Effectiveness parameters: meibomian gland (MG) assessment, tear break-up time (TBUT) and dry eye symptoms. Safety parameters: adverse events, ocular health exam, ocular surface staining, intraocular pressure, visual acuity and discomfort. RESULTS: LipiFlow resulted in significant improvement (P < 0.05) in MG secretion at 2 and 4 weeks (mean ± standard deviation at baseline = 6.3 ± 3.5; 2 weeks = 14.3 ± 8.7; 4 weeks = 16.7 ± 8.7); and TBUT at 2 and 4 weeks: (at baseline = 5.5 ± 2.9; 2 weeks = 6.9 ± 5.0; 4 weeks = 7.4 ± 5.5). There was no significant change in MG secretion or TBUT in the control group. LipiFlow resulted in a greater significant reduction in dry eye symptoms than the iHeat WC. The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow. There was no significant difference between groups in the incidence of non-serious, device-related adverse events. CONCLUSION: The LipiFlow System was significantly more effective than iHeat WC. These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms.

LASIK correction of spherical hyperopia, hyperopic astigmatism, and mixed astigmatism with the LADARVision excimer laser system.

OBJECTIVE: To assess the safety and effectiveness of the LADARVision active tracking narrow beam excimer laser system (Alcon Surgical, Orlando, FL) using laser in situ keratomileusis (LASIK) for correction of spherical hyperopia, hyperopic astigmatism, and mixed astigmatism. DESIGN: A multicenter, prospective non-randomized (self-controlled) comparative trial. PARTICIPANTS: A total of 360 eyes, including 152 spherical hyperopic, 143 hyperopic astigmatic, and 65 mixed astigmatic, were treated for up to +6.00-diopter (D) sphere with up to -6.00-D cylinder. INTERVENTION: Treatments were performed at six sites in the United States using a 6-mm optic zone with a 1.5-mm peripheral blend zone for a maximum ablation zone diameter of 9 mm. MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA), manifest refraction, vector analysis, best spectacle-corrected visual acuity (BSCVA), complications and adverse reactions, subjective symptoms, and patient satisfaction. RESULTS: Six and 12 months of follow-up, respectively, were available on 143 and 117 spherical hyperopic eyes, 124 and 74 hyperopic astigmatic eyes, and 57 and 38 mixed astigmatic eyes, respectively. For spherical hyperopes at 6 and 12 months, UCVA was 20/40 or better in 93.4% and 93.9% of eyes, respectively. The manifest refraction spherical equivalent (MRSE) was within 0.50 D of intended in 65.0% and 74.1% of eyes, respectively, and within 1.00 D in 87.4% and 91.4%, respectively. Refractive stability was demonstrated in 94.2% or more of eyes between the intervals of 1 to 3 months and 3 to 6 months and in 95.3% or more of eyes to 12 months. A loss of two lines of BSCVA occurred in 3.5% and 3.4%, respectively, and no eyes lost more than two lines. For hyperopic astigmats at 6 and 12 months, UCVA was 20/40 or better in 90.9% and 93.8% of eyes, respectively. The MRSE was within 0.50 D of intended in 60.5% and 73.0% of eyes, respectively, and within 1.00 D in 88.7% and 89.2% of eyes, respectively. Refractive stability was demonstrated in 96.5% or more of eyes, respectively, between the intervals of 1 to 3 months and 3 to 6 months and 95.5% or more to 12 months. A loss of two lines of BSCVA occurred in 5.8% and 1.4% of eyes, respectively, and no eyes lost more than two lines. For mixed astigmats at 6 and 12 months, UCVA was 20/40 or better in 92.6% and 94.4% of eyes, respectively. The MRSE was within 0.50 D of intended in 64.9% and 73.7% of eyes, respectively, and within 1.00 D in 87.7% and 94.7% of eyes, respectively. Refractive stability was demonstrated in 100% of eyes between the intervals of 1 to 3 months and 3 to 6 months and in 97.0% or more to 12 months. A loss of two lines of BSCVA occurred in 1.9% and 0.0% of eyes, respectively, and no eyes lost more than two lines. CONCLUSIONS: The data support safety and effectiveness of the LASIK correction of spherical hyperopia, hyperopic astigmatism, and mixed astigmatism with the LADARVision system.