The Living Lamellar Lens™

Excimer Customized, Trans-Epithelial Epikeratophakia

New from iVIS Technologies is the Living Lamellar Lens, an innovative, patent applied for, refractive surgical procedure primarily for the correction of high myopia and hyperopia.  Utilizing the high precision technologies available within the iVIS Suite, the Living Lamellar Lens integrates the experience of iVIS’ advanced shape based surgical planning with proprietary methods to correct refractive power ranges previously impractical or impossible. Importantly the Living Lamellar Lens incorporates the safety, precision, and low trauma of a surface based surgery.

Developed as a sister procedure to CLAT™ (Corneal Lamellar Ablation for Transplantation), the Living Lamellar Lens is an intelligent, automated refractive surgical procedure that expands the refractive treatment range for high myopia, and high hyperopia. The Living Lamellar Lens is a significant improvement on older keratome (mechanical or femtosecond laser) based surgical strategies by providing improved corneal optics and shorter recuperation periods.

The Process

1.  Trans-Epithelial Receiving Surface Preparation
Utilizing HD (High-Definition), 3-D corneal elevation and pachymetry data from Precisio™, a custom, trans-epithelial treatment is planned using the surgical design software, CIPTA. This custom ablation is then performed on the patient’s cornea with a perimeter limiting, circular mask in place.
  • The mask provides a vertical edge to the border of the prepared receiving surface. Additionally the mask defines the precise, matching dimension to the Living Lamellar Lens, without the use of high-suction applanation / deformation required with keratomes (mechanical or laser).

The Living Lamellar Lens receiving surface is custom designed using CIPTA software and created with the iRES laser.
  • The custom receiving surface ablation removes the epithelium and corrects the rotationally critical corneal refractive errors: regular astigmatism, irregular astigmatism, and other aberrations above the second order.
  • Importantly, the receiving surface ablation preserves both the pre-operative medium K value and the natural asphericity.
  • The receiving surface interface is remarkably smooth in contrast to that seen with older techniques such as manual, mechanical keratome, or femtosecond laser dissection.
  • The iRES™ laser performs this step typically in only 10 to 15 seconds.
2.  Refractive and Minimizing Lamella Shaping

The lamella (donor tissue) is first mounted to present the endothelial aspect for shaping by the refractive laser. In a single step, the following features are created: .

  • The lamella’s optical zone is ablated to correct the remaining refractive error:  the large spherical component. This optical zone conforms to the “Ideal Pupil™” dimension from the pMetrics™ pupillometer.
  • Simultaneously, the laser uniformly thins the full
    lamellar surface to leave a thickness minimized     lamella (e.g. 50 microns). This critical step develops the refractive lamella element so as to be physiologically minimized.

 

The Living Lamellar Lens is shaped posteriorly to account for large refractive errors and then the thickness is minimized.
  • This refractive and minimizing shaping typically is completed in only 30 to 40 seconds.
  • Optionally, if the tissue has been acquired without a trephine finished diameter, the lamellar diameter may be precision laser cut using the iRES laser’s exclusive iTrefine™ feature.
3.  Lamella Anterior - Peripheral Shaping
The minimized refractive lamella is then inverted to present the anterior aspect for final laser shaping.
  • The iRES laser applies an anterior, peripheral, parabolic blend extending exactly from the perimeter of the posterior optical zone (also equal to the Ideal Pupil dimension) to the edge of the lamella.

The Living Lamellar Lens anterior surface is shaped periperally using a parabolic blend.
  • This parabolic blend completes the development of the Living Lamellar Lens by further minimizing the volume of the lamella.
  • The lamella edge thickness has also been sized to be coincidental with the receiving surface’s vertical cut.
  • The anterior-peripheral shaping is typically performed in only 30 to 40 seconds.
4.  The Living Lamellar Lens Placement

The completed Living Lamellar Lens is placed by the surgeon onto the prepared receiving surface.

  • A bandage soft contact lens is applied to secure and protect the lamella during the re-epithelialization process. 
  • Just as with a free-cap LASIK procedure, no sutures are normally required to secure the Living Lamellar Lens.

The Living Lamellar Lens is placed by the surgeon into the receiving surface and then covered with a bandage contact lens for re-epithelialization.

Clinical Applications

Many patients that had not been candidates for refractive surgery prior may be considered for the Living Lamellar Lens:
  • High Myopia and Myopic Astigmatism
  • High refractive errors with irregular astigmatism or "Complex Corneas"
  • High Hyperopia and Hyperopic Astigmatism
  • Prior Refractive Surgery Failures:
    • High residual refractive errors with or without irregular astigmatism
    • Cornea that is too thin to support additional refractive surgery
    • Very large pupils with thin corneas