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Improved lenticule shape for hyperopic femtosecond lenticule extraction (ReLEx® FLEx): a pilot study

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Abstract

The aim of this study is to establish and to prove a new lenticule shape for the treatment of hyperopia using a 500 kHz femtosecond laser and the femtosecond lenticule extraction (ReLEx® FLEx) technique. Improved lenticule shapes with a large transition zone of at least 2 mm adjusted to the 5.75 mm optical zone were designed. A prospective pilot study on nine eyes of five patients who underwent an uncomplicated FLEx using VisuMax® femtosecond laser (Carl Zeiss Meditec AG) for spherical hyperopia was performed. Patients’ mean age was 55.5 years, and the preoperative manifest spherical equivalent (SE) was +1.82 D (range +1.25 to +3.00 D). Because of the presbyopic age and in order to compensate for a possible regression, the treatment was aimed at low myopia (mean target SE was −0.88 D with a mean treatment refraction of +2.69 D). At the last follow-up, after 9 months, 33 % were within ±0.50 D and 78 % within ±1.00 D of intended correction. Thirty-three percent lost one line, and 11 % gained one line corrected distance visual acuity (CDVA). On average, the centre of the optical zone was 0.34 ± 0.17 mm from the corneal vertex. No adverse effects were observed. This pilot study confirms that the improved lenticule’s design with a large optical and transition zone can achieve good centration and acceptable results for spherical hyperopia using FLEx. The next steps are to extend the study to spherocylindrical hyperopic treatments and to increase the number of eyes for better assessment of refractive outcome.

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Authors and Affiliations

  1. Department of Ophthalmology, Philipps University of Marburg, Baldinger Strasse, 35043, Marburg, Germany

    Walter Sekundo

  2. London Vision Clinic, 138 Harley Street, London, W1G 7LA, UK

    Dan Z. Reinstein

  3. Department of Ophthalmology, HELIOS-Hospital Erfurt, Erfurt, Germany

    Marcus Blum

Authors
  1. Walter Sekundo
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  2. Dan Z. Reinstein
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  3. Marcus Blum
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Corresponding author

Correspondence to Walter Sekundo.

Ethics declarations

This prospective study was approved by the Ethics Committee of the Chamber of Physicians of Thuringia, Germany, as well as by the Institutional Review Board of the Philipps University of Marburg, Germany. The Ethics Committees recommended to divide the study in a pilot study with 10 eyes (initial spherical cohort) and to proceed with a larger study (40 eyes, second, spherocylindrical cohort) only after the first treatment group has been followed up and reported appropriately. An informed consent was obtained from each patient.

Conflict of interest

This study was supported by Carl Zeiss Meditec AG, Jena, Germany. Professor Reinstein is a consultant for Carl Zeiss Meditec AG and has a financial interest in the Artemis technology (ArcScan Inc, Morrison, CO). Professor Sekundo is a Member of the Scientific Advisory Board of Carl Zeiss Meditec AG, Jena, Germany. Professors Blum and Sekundo received honoraria from Carl Zeiss Meditec for corporate presentations in the past. The authors certify that they have no other affiliations (except from the above mentioned) with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.

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Sekundo, W., Reinstein, D.Z. & Blum, M. Improved lenticule shape for hyperopic femtosecond lenticule extraction (ReLEx® FLEx): a pilot study. Lasers Med Sci 31, 659–664 (2016). https://doi.org/10.1007/s10103-016-1902-2

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  • DOI: https://doi.org/10.1007/s10103-016-1902-2

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