An interventional study of Penetrating keratoplasty and Femtosecond laser in Keratoconus, Corneal Dystrophies and Corneal Opacity, sponsored by Ospedale Santo Stefano. Completed at 1 site in Italy. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-06-25.
Sponsored by Ospedale Santo Stefano · Not applicable, Interventional, and Treatment
Laser- assisted procedures in penetrating keratoplasty (PK) are proposed to improve the surgical outcomes: minimally invasive procedures, improved biomechanical stability of the transplanted flap, reduction of rejection risks, reduction of inflammation, reduction of infections risk, faster healing process.
In order to achieve these goals, two different lasers were used during PK surgery:
The femtosecond laser is used to cut an anvil-shaped laser incision used in PK. This design has the purpose to create a more structurally stable and predictable wound configuration with the aim of a faster recovery of vision and higher optical quality, compared with the conventional blade trephination and the most common laser-cut patterns. The "anvil" profile is designed as described in the followings. Donor and recipient corneal trephination are performed using a 150 kHz FS laser (iFS150TM, IntralaseTM FS Laser, Abbott Medical Optics -AMO, Santa Ana, CA, USA). As concerned iFS150 settings, we refer to the following technical parameters: in the donor graft, the outer and inner diameters of the ring lamellar cut at 350 µm in depth were set at 8.5 mm and 6.6 mm, respectively; the anterior-side cut started with an angle of 135° at a diameter of 7.7 mm, while the straight posterior side cut diameter was 6.7 mm. In the recipient eye, the diameters were designed to be 0.2 mm shorter (8.3 mm outer diameter, 6.4 mm inner diameter, 7.5 mm anterior side cut and 6.5 mm posterior side cut). After completion of the trephination, the corneal button was gently lifted from the host and the donor graft was secured in place on the recipient bed by means of 10-0 nylon cardinal sutures, which were removed after the final 16-running 10-0 nylon suture was completed. A similar FS-laser cut procedure producing a 0.2 mm-narrower corneal bed -diameter is performed on the patient's recipient eye. After completion of the trephination, the corneal button is lifted gently from the host and the donor graft is secured into place with 10-0 nylon cardinal sutures, that are removed as a running 10-0 nylon suture is placed.
The particular "anvil" shape of the graft provides a larger contact surface in between donor and recipient cornea, which enables an effective application of the diode laser welding technique of corneal wounds we have previously set up in cataract and PK applications (Menabuoni et al. 2007, Rossi et al. 2008). This laser-assisted suturing technique is based on the photothermal activation of the stromal collagen, providing an immediate sealing of the surgical wound and a good stabilization of the graft. Once the donor graft was sutured in its final position, diode laser welding was performed. A sterile saturated water solution of 10% w/v Indocyanine Green (ICG) (Pulsion Medical System AG, Munich, Germany) was prepared and applied to the walls of the surgical wound at the donor-recipient interface. A mild photothermal effect was induced by means of a near infrared diode laser (Mod. WELD 800, El.En., Calenzano, FI, Italy) that emitted at 810 nm. The laser light was delivered through a 300-micron core diameter optical fiber that was mounted on a handpiece and used "as a pencil" by the surgeon under a surgical microscope. In a slow, continuous/fluid motion, the surgeon moved the fiber tip along the wound edge at a distance of 1.5 mm from the external surface of the cornea. The power radiation emitted was a 60 mW continuous wave, which resulted in an 8 W/cm2 power density on the tissue surface. The laser welding treatment time was set at 130s.
Thanks two the combine laser assisted procedures, the possible reduction of suture materials allows a faster and improved the healing process, with minimal inflammation and reaction. Thus the combination of FS laser trephination with the diode laser welding technique may provide extremely precise, and minimally invasive surgical procedures in PK.
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 22 is below the median of 40 across 205 interventional studies indexed under Keratoconus.
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Femtosecond laser sculptured anvil graft. Diode laser welding of the flap in its final position. 12 months follow up study
Procedure: Penetrating keratoplasty · Device: Femtosecond laser · Device: Diode laser
Femtosecond laser sculptured anvil graft. Laser welding of the flap in its final position. 12 months follow up study
A commercial femtosecond laser to cut a particular shaped graft
Low power, near infrared diode laser for welding the surgical wound
Change in best spectacle-corrected distance visual acuity (CDVA)
documentation of the visual acuity of patients
Time frame: 1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery
Change in objective astigmatism and specular corneal topography
Objective astigmatism and specular corneal topography were evaluated by using a topographer-pachymeter
Time frame: 1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery
Change in anterior segment optical coherence tomography
All patients underwent anterior segment optical coherence tomography to evaluate wound alignment and suture configurations
Time frame: 1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery
The record gives a start of Jan 2011, a primary completion of Jan 2013 and a completion of Sep 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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