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James E Hill, Brad Gray, Ling Huang, William F Wiley, Kevin L Waltz, Carrie Garufis, LeAnne Connolly; Evaluation of Femtosecond Laser-assisted Clear Corneal and Paracentesis Incisions for Cataract Surgery. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3129.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate femtosecond laser-assisted clear corneal and paracentesis incisions on human cadaver eye tissue and in a clinical setting. Clinical trial Cleveland, Ohio, NCT01713660, 10-23-12 registered, trial start 11-6-12.
Using human eye bank tissue, one and three-plane corneal incisions, paracentesis (P) and clear corneal incision (CCI), respectively, were created using the Advanced Femtosecond Laser (iFS) laser (pulse energy 2.1 µJ, spot and layer separation of 2x2µm). CCI widths ranged from 2.2 to 3.5 mm, and P widths ranged from 0.8 to 1.2mm. Wound architecture evaluated by Optical Coherence Tomography (OCT). Corneal leakage assessed by Seidel test (with fluorescein). The iFS laser-assisted incisions were measured using Deacon-Steinert gauges. The confirmatory clinical study was performed with 10 patients (n = 10 eyes). The incision size (slit lamp beam width), architecture (OCT) and leakage (Seidel test) were evaluated immediately post laser treatment prior to cataract surgery.
The iFS laser created CCI and P incisions consistently, achieving incision widths within 0.1 mm of intended target (based upon Deacon-Steinert gauge for human cadaver eye tissue and by slit lamp beam width in clinical trial). OCT scans showed that the target incision steps and depths were achieved. In all cases Seidel testing was negative, indicating the iFS laser-assisted incisions did not leak before opening them with a surgical instrument.
Results from these two studies (cadaver eye evaluation and clinical study) were consistent in outcomes. Clear corneal and paracentesis incisions created with the iFS laser were accurate, repeatable, and Siedel negative. OCT scans demonstrate that these incisions have a precise construction, with clear defined planes at consistent corneal depths.
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