Femtosecond lenticule extraction for the correction of myopia: preliminary 6-month results

Blum, Marcus; Kunert, Kathleen S.; Schröder, M.; Sekundo, Walter

doi:10.1007/s00417-009-1293-1

Cited by 146 publications

(124 citation statements)

References 19 publications

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“…9 Few studies are available to validate the outcome of the procedure, which has obtained CE Mark approval in 2009 but yet to be approved by the United States Food and Drug Administration. [7][8][9][10] Initial clinical results have been promising, where postoperative refractive outcomes were comparable to standard LASIK with few complications. 11,12 However, more studies are needed to assess the safety and efficacy of this new surgical procedure.…”

mentioning

confidence: 93%

“…10 After application of topical anesthesia, standard sterile draping and insertion of the speculum, the patient's eye was centered and docked with the curved interface cone before application of suction fixation. The laser treatment started with the posterior surface of the refractive lenticule (spiral in) before the lenticule border was created.…”

Section: A Prospective Clinical Studymentioning

confidence: 99%

“…In ReLEx, the FS laser cuts an intrastromal lenticule corresponding to the patients' refractive correction, which is removed through a surface incision of varying size depending on whether the FLEx or SMILE procedure is being performed (specific techniques are discussed in detail in the Methods). 10 In FLEx, the laser creates a flap (similar to LASIK), which is reflected, allowing lenticule removal. SMILE, a 'flapless ' surgery, allows lenticule removal through a small 2 to 4 mm incision.…”

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confidence: 99%

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Femtosecond Lenticule Extraction (FLEx): Clinical Results, Interface Evaluation, and Intraocular Pressure Variation

Ang

Chaurasia

Angunawela

et al. 2012

Invest. Ophthalmol. Vis. Sci.

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PURPOSE.To characterize the clinical profile of femtosecond lenticule extraction (FLEx) correlated with ultrastructural analysis of the corneal interface and in vivo real-time intraocular pressure (IOP). METHODS. Prospective clinical case series with experimental studies; consecutive patients underwent FLEx at a single tertiary center over 10 months with postsurgical follow-up of 3 months. The patients were divided into three groups according to spherical equivalence (SE) (A, Ͻ Ϫ5.0 diopters [D]; B, Ն Ϫ5.00 D and Ͻ Ϫ9.00 D; and C, Ն Ϫ9.0 D). Twelve human cadaveric eyes analyzed using scanning electron microscopy after receiving FLEx; 40 rabbit eyes received FLEx with in vivo IOP measurements. The main outcome measures were refractive outcomes from study subjects; with corneal interface and IOP in experimental studies. RESULTS. Thirty-three subjects (22 females, 66.7%) underwent FLEx in both eyes (66 eyes). Mean age was 32 years (range, 21 to 46 years). Preoperative mean SE was Ϫ5.77 Ϯ 2.04 D with astigmatism of Ϫ1.03 Ϯ 0.72 D. There was a slight hyperopic shift (mean SE 0.14 Ϯ 0.53 D); 94% achieved uncorrected visual acuity Ն20/25 3 months postoperatively. Refractive stability was achieved within 1 month (P Ͻ 0.001). Ultrastructurally, the smoothness of the corneal interface was independent of ablation depth (mean irregularity scores A, B, C: 8.8 Ϯ 0.6, 10.3 Ϯ 0.4, 8.7 Ϯ 0.6, respectively; P ϭ 0.88). The increase in IOP during FLEx was similar to that in femtosecond (FS)-LASIK, albeit a twofold duration of raised IOP in FLEx (P Ͻ 0.001). CONCLUSIONS. These results suggest that FLEx is predictable and effective in treating myopia and myopic astigmatism. Experimental studies support the early clinical results and safety of this procedure. (Invest Ophthalmol Vis Sci. 2012;53: 1414 -1421) DOI:10.1167/iovs.11-8808 T he femtosecond (FS) laser is a near-infrared neodymiumdoped yttrium aluminum garnet (ND:YAG) laser that photodisrupts the cornea with surgical precision through plasma cleavage of stromal lamellae.1 The first commercial ophthalmic FS laser was introduced into the market in 2001 for laser in situ keratomileusis (LASIK) flaps. Since then, significant improvements in laser energy profiles, spatial resolution, and faster laser speeds have occurred.2 FS lasers have thus made a significant impact on refractive surgery by enabling nonmechanical creation of a corneal flap during LASIK. The FS laser offers several advantages over manual microkeratomes including increased precision, reduced incidence of flap complications, and the ability to cut thinner flaps without the risk of buttonhole formation.3,4 Moreover, newer generation FS lasers have reduced problems such as transient lightsensitivity syndrome and interference by cavitation bubbles. 5,6

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confidence: 93%

Section: A Prospective Clinical Studymentioning

confidence: 99%

mentioning

confidence: 99%

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Femtosecond Lenticule Extraction (FLEx): Clinical Results, Interface Evaluation, and Intraocular Pressure Variation

Ang

Chaurasia

Angunawela

et al. 2012

Invest. Ophthalmol. Vis. Sci.

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“…ingrowth and monocular ghost images. 10,11,19 Recently, we found irregular postoperative topography in 18 of 1,574 eyes, giving rise to ghost images in six cases. 23 Topography-guided PRK was performed in four of these eyes, ameliorating the symptoms in three cases.…”

Section: Safetymentioning

confidence: 97%

New Developments in the Lenticule Extraction Procedure

Hjortdal¹,

Ivarsen²

2014

European Ophthalmic Review

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31Over the last few years, surgical extraction of a refractive lenticule, or ReLEx ® , has evolved as a new treatment in the field of keratorefractive surgery. Currently, the VisuMax ® femtosecond (FS) laser (Carl Zeiss Meditec, Jena, Germany) is the only platform to offer this treatment.The 500 kHz VisuMax laser generates very fast pulses (10 -15 s range) in the near-infrared spectrum. Depending on the specific laser settings, each pulse conveys approximately 150 nJ, which causes localised photodisruption at the focal point. The generated plasma expands, creating a cavitation bubble, and, as individual cavitation bubbles fuse, the stroma is cut with a minimum of collateral damage. The VisuMax FS laser uses a high numerical aperture and a concave contact glass to focus the laser pulses with very high precision. Thus, laser spots of approximately 1 μm diameter are placed with a defined distance of 2-5 μm in a spiral pattern. To ensure centration on the visual axis, the patient fixates on a blinking light and suction is applied at the limbus to maintain stability of the eye. Initially, the posterior refractive surface of the lenticule is cut, followed by creation of the plano anterior surface, which is slightly enlarged in diameter to facilitate surgical manipulation.This review article reviews the current state of the technique, updated clinical results, 1 experimental studies and, finally, presents some of the challenges that need to be addressed by new technologies.Depending on the method used to access the lenticule, ReLEx can be split into FLEx, in which a laser-assisted in situ keratomileusis ( In contrast to LASIK, ReLEx is a one-laser approach, where the critical laser treatment is performed on the intact cornea rather than on exposed corneal stroma. Consequently, the potential variability associated with the excimer laser photoablation is avoided.In addition, the minimally invasive SMILE treatment has several theoretical advantages over flap-based treatments, including little trauma to the corneal surface, less corneal denervation and better biomechanical strength due to an almost intact anterior stroma. Since AbstractFor the last 20 years controlled excimer laser ablation of corneal tissue, either directly from the corneal stromal surface or from the corneal interior after creation of a superficial corneal flap, has become widely used to correct myopia, hyperopia and astigmatism.Recently, an intrastromal refractive procedure whereby a tissue lenticule is cut free in the corneal stroma by a femtosecond laser and removed through a small peripheral incision has been introduced. The procedure avoids creation of a corneal flap and the potential associated risks while avoiding the slow visual recovery of surface ablation procedures. The all-femtosecond-based flap-free intracorneal refractive procedure has been documented to be a predictable, efficient and safe procedure for correction of myopia and astigmatism. Technological developments related to further improved cutting quality, hyperopic and individualise...

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“…In the first clinical studies, ReLEx flex was reported to have delayed visual recovery in comparison with FS-LASIK [11,27]. However, later studies suggested that the laser scanning pattern and energy had an impact on the lenticule surface quality and the immediate postoperative outcome [28 • , 29, 30].…”

Section: Visual Outcomementioning

confidence: 99%

All-Femtosecond Laser Keratorefractive Surgery

Ivarsen

Hjortdal

2013

Curr Ophthalmol Rep

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During the last few years, refractive lenticule extraction (ReLEx) has been introduced as a new approach in the field of keratorefractive surgery. In contrast to previous treatments, ReLEx is an all-femtosecond laser treatment where a refractive lenticule is created within the intact cornea. The lenticule can be removed using a flapbased approach (ReLEx flex), but in its latest evolution (ReLEx smile), the lenticule is extracted through a small peripheral incision, leaving most of the anterior stroma untouched. In theory, this approach should spare most of the corneal nerves and minimize the biomechanical impact of the procedure. Clinical studies have shown the safety and the visual and refractive outcomes after ReLEx to be as good as after FS-LASIK. The current article aims to provide an up-to-date overview of all-femtosecond laser keratorefractive surgery with particular emphasis on the most current of approach, ReLEx smile.

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Femtosecond lenticule extraction for the correction of myopia: preliminary 6-month results

Abstract: FLEx appears to be a safe and promising corneal refractive procedure for correcting myopia.

Cited by 146 publications

References 19 publications

Femtosecond Lenticule Extraction (FLEx): Clinical Results, Interface Evaluation, and Intraocular Pressure Variation

Femtosecond Lenticule Extraction (FLEx): Clinical Results, Interface Evaluation, and Intraocular Pressure Variation

New Developments in the Lenticule Extraction Procedure

All-Femtosecond Laser Keratorefractive Surgery

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