Aim This 6 month prospective multi-centre study evaluated the feasibility of performing myopic femtosecond lenticule extraction (FLEx) through a small incision using the small incision lenticule extraction (SMILE) procedure. Design Prospective, non-randomised clinical trial. Participants Ninety-one eyes of 48 patients with myopia with and without astigmatism completed the final 6 month follow-up. The patients9 mean age was 35.3 years. Their preoperative mean spherical equivalent (SE) was −4.75±1.56 D. Methods A refractive lenticule of intrastromal corneal tissue was cut utilising a prototype of the Carl Zeiss Meditec AG VisuMax femtosecond laser system. Simultaneously two opposite small ‘pocket’ incisions were created by the laser system. Thereafter, the lenticule was manually dissected with a spatula and removed through one of incisions using modified McPherson forceps. Main outcome measures Uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BSCVA) after 6 months, objective and manifest refraction as well as slit-lamp examination, side effects and a questionnaire. Results Six months postoperatively the mean SE was −0.01 D±0.49 D. Most treated eyes (95.6%) were within ±1.0 D, and 80.2% were within ±0.5 D of intended correction. Of the eyes treated, 83.5% had an UCVA of 1.0 (20/20) or better, 53% remained unchanged, 32.3% gained one line, 3.3% gained two lines of BSCVA, 8.8% lost one line and 1.1% lost ≥2 lines of BSCVA. When answering a standardised questionnaire, 93.3% of patients were satisfied with the results obtained and would undergo the procedure again. Conclusion SMILE is a promising new flapless minimally invasive refractive procedure to correct myopia.

https://hal.archives-ouvertes.fr/hal-00567046/document

Small incision corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study

Purpose To report the clinical results of small incision lenticule extraction to correct refractive errors using a femtosecond laser to refine the femtosecond lenticule extraction technique. Setting Private laser center, Vadodara, India. Design Prospective clinical study. Methods The VisuMax femtosecond laser system was used to perform small incision lenticule extraction to treat refractive errors. The laser was used to cut a refractive lenticule intrastromally to correct myopia and myopic astigmatism. The lenticule was then extracted from the stroma through a 3.0 to 5.0 mm incision. Outcome measures were corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), and manifest refraction during 6 months of follow-up. Corneal topography and ocular wavefront aberrations were also measured. Results The study enrolled 51 eyes of 41 patients. The mean spherical equivalent was −4.87 diopters (D) ± 2.16 (SD) preoperatively and +0.03 ± 0.30 D 6 months postoperatively. Refractive stability was achieved within 1 month ( P Conclusion All-in-one femtosecond refractive correction using a small incision technique was safe, predictable, and effective in treating myopia and myopic astigmatism. Financial Disclosure No author has a financial or proprietary interest in any material or method mentioned. Additional disclosure is found in the footnotes.

Results of small incision lenticule extraction: All-in-one femtosecond laser refractive surgery

Biomechanics and wound healing in the cornea

Some background as well as recent progress in the development of femtosecond lasers are discussed together with a brief outline of a few representative emergent applications in biology and medicine that are underpinned by access to such sources. We also provide a short summary of other contributions in this focus issue.

The development and application of femtosecond laser systems

Purpose To present initial clinical experience with small-incision lenticule extraction for the treatment of moderate to high myopia. Setting Department of Ophthalmology, Aarhus University Hospital, Aarhus, Denmark. Design Prospective clinical study. Methods For small-incision lenticule extraction, an intrastromal lenticule was cut with a femtosecond laser and manually extracted without creation of a flap. Patients were treated and followed for 3 months. Only 1 randomly chosen eye of each patient was used in the statistical analyses. Results The study enrolled 144 patients. The mean preoperative spherical equivalent was −7.18 diopters (D) ± 1.57 (SD). Of eyes with emmetropia as target refraction, 40% had an uncorrected distance visual acuity of 0.1 logMAR or less 1 day after surgery; this increased to 73% at 3 months. The mean corrected distance visual acuity (CDVA) improved significantly from −0.01 (logMAR) preoperatively to −0.03 3 months postoperatively. None of the 127 eyes lost 2 lines or more of CDVA and 6 eyes lost 1 line of CDVA after 3 months. In contrast, 1 eye gained 2 lines and 24 eyes gained 1 line of CDVA. The achieved refraction was a mean of −0.09 ± 0.45 D from the attempted refraction. Of the eyes, 77% were within ±0.50 D and 95% were within ±1.00 D. Ninety-five percent of the patients would recommend the procedure to others. Conclusions The refractive predictability, safety, and patient satisfaction 3 months after small-incision lenticule extraction were high and comparable to results in previous studies of femtosecond laser–assisted techniques. Financial Disclosure Drs. Hjortdal and Asp received travel reimbursement from Carl Zeiss Meditec AG, Jena, Germany. No other author has a financial or proprietary interest in any material or method mentioned.

Small-incision lenticule extraction for moderate to high myopia: Predictability, safety, and patient satisfaction

Purpose To prospectively study the feasibility of femtosecond lenticule extraction (FLE), a new method of refractive correction. Setting Department of Ophthalmology, Philipps University of Marburg and Helios Clinic, Erfurt, Germany. Methods A flap and a lenticule of intrastromal corneal tissue were simultaneously cut with a VisuMax femtosecond laser system. Next, the lenticule was manually removed and the flap repositioned. The target refraction in all cases was −0.75 diopter (D). Results All 10 myopic eyes in the initial treatment group completed the final 6-month follow-up. The mean patient age was 39 years. The mean spherical equivalent (SE) was −4.73 ± 1.48 (SD) preoperatively and −0.33 ± 0.61 D 6 months postoperatively. Ninety percent of eyes were within ±1.00 D and 40% were within ±0.50 D of the intended correction. No eye lost 2 or more Snellen lines. Corneal topography showed large, prolate optical zones. Aberrometry showed no significant induction of higher-order aberrations. On a standardized questionnaire, all patients said they were very satisfied with the results. Conclusions Preliminary results indicate that FLE is a promising new corneal refractive procedure to correct myopia.

First efficacy and safety study of femtosecond lenticule extraction for the correction of myopia: six-month results.

The invention relates to a contact glass for ophthalmic surgery. Said glass comprises a lens body (22) that is held in a frame (37) and a front lens surface (29) that is designed to be placed against the eye (2). According to the invention, the front lens surface (29) is concave and follows a surface curvature (K) and an annular gap (44) is formed at the edge of the front lens surface (29) between the lens body (22) and the frame (37), said gap being used to apply a negative pressure in order to fix the contact glass (12) to the eye (2). The frame (37) is designed to follow the contour of an imaginary continuation of the surface curvature (K), or at least does not project beyond the latter.

Contact glass for ophthalmic surgery

A treatment method and apparatus for surgical correction of defective-eyesight in an eye of a patient, wherein a laser device is controlled by a control device, said laser device separating corneal tissue by irradiation of laser radiation to isolate a volume located within a cornea, wherein the control device controls the laser device to focus the laser radiation, by providing target points located within the cornea, into the cornea, wherein the control device, when providing the target points, allows for focus position errors which lead to a deviation between the predetermined position and the actual position of the target points when focusing the laser radiation, by pre-offsets depending on the positions of the respective target points to compensate for said focus position errors.

Treatment apparatus for surgical correction of defective eyesight, method of generating control data therefore, and method for surgical correction of defective eyesight

A surgical structure to be introduced into the eye by means of an excimer or femtosecond laser must be positioned exactly in the co-ordinate system of the laser. By recording monitoring images and comparing the actual position and the desired position of the pupil it is possible to detect a movement of the structure and/or the patient in order to compensate for deviations. Nevertheless a suboptimal treatment can take place, after which vision is not optimal, in particular in dark environments. The invention is intended to enable improved vision after laser treatments. For this purpose an evaluation unit is provided, which is designed to detect a degree of current overlap of an optical zone of the eye and the structure or at least a refractively correcting part of the structure with the aid of a recorded image. By the detection of the degree of overlap between the current optical zone and the structure to be introduced it is possible to control the coverage of the optical zone by the tissue volume specifically altered by means of laser processing and thus to enable maximum coverage.

Ophthalmological laser treatment device

A treatment apparatus for operatively correcting myopia or hyperopia in an eye includes a laser device controlled by a control device and that separates the corneal tissue by applying a laser beam. The control device controls the laser device to emit the laser beam into the cornea such that a lenticule-shaped volume is isolated in the cornea. The control device, when controlling the laser device, predefines the lenticule-shaped volume such that the volume has a minimum thickness of between 5 and 50 μm. For myopia correction, the minimum thickness occurs on the edge of the volume, and for hyperopia correction the minimum thickness occurs in the region of the visual axis.

Treatment device for operatively correcting defective vision of an eye, method for producing control data therefor and method for operatively correcting defective vision of an eye

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