Laser Assisted Procedures in Penetrating Keratoplasty

Laser Assisted Procedures in Penetrating Keratoplasty: Femtosecond Laser Anvil-shaped Cuts and Laser Welding of the Surgical Wounds

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:

• a femtosecond laser to cut an anvil shaped profile
• a diode laser to weld the surgical wound

Study Overview

• Status: Completed
• Conditions: Corneal Opacity; Keratoconus; Corneal Dystrophies
• Intervention / Treatment: Procedure: Penetrating keratoplasty; Device: Femtosecond laser; Device: Diode laser

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Prato, Italy, 59100
    • U.O. Oculistica Nuovo Ospedale S. Stefano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Corneal dystrophy
• keratoconus in its final stages
• post-herpetic leukoma
• corneal scar

Exclusion Criteria:

• systemic diseases
• previous corneal surgery
• glaucoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Penetrating keratoplasty; Femtosecond laser sculptured anvil graft. Diode laser welding of the flap in its final position. 12 months follow up study	Procedure: Penetrating keratoplasty; Femtosecond laser sculptured anvil graft. Laser welding of the flap in its final position. 12 months follow up study; Device: Femtosecond laser; A commercial femtosecond laser to cut a particular shaped graft; Device: Diode laser; Low power, near infrared diode laser for welding the surgical wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in best spectacle-corrected distance visual acuity (CDVA)	documentation of the visual acuity of patients	1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in objective astigmatism and specular corneal topography	Objective astigmatism and specular corneal topography were evaluated by using a topographer-pachymeter	1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anterior segment optical coherence tomography	All patients underwent anterior segment optical coherence tomography to evaluate wound alignment and suture configurations	1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery

Collaborators and Investigators

• Sponsor: Ospedale Santo Stefano
• Collaborators: Istituto di Fisica Applicata
• Investigators: Principal Investigator: Luca Menabuoni, MD, Head of Corneal and Experimental Surgery at the Department of Ophthalmology

Publications and helpful links

General Publications

• Buzzonetti L, Capozzi P, Petrocelli G, Valente P, Petroni S, Menabuoni L, Rossi F, Pini R. Laser welding in penetrating keratoplasty and cataract surgery in pediatric patients: early results. J Cataract Refract Surg. 2013 Dec;39(12):1829-34. doi: 10.1016/j.jcrs.2013.05.046. Epub 2013 Oct 18.
• Rossi F, Matteini P, Ratto F, Menabuoni L, Lenzetti I, Pini R. Laser tissue welding in ophthalmic surgery. J Biophotonics. 2008 Sep;1(4):331-42. doi: 10.1002/jbio.200810028.
• Menabuoni L, Pini R, Rossi F, Lenzetti I, Yoo SH, Parel JM. Laser-assisted corneal welding in cataract surgery: retrospective study. J Cataract Refract Surg. 2007 Sep;33(9):1608-12. doi: 10.1016/j.jcrs.2007.04.013.
• Rossi F, Pini R, Menabuoni L. Experimental and model analysis on the temperature dynamics during diode laser welding of the cornea. J Biomed Opt. 2007 Jan-Feb;12(1):014031. doi: 10.1117/1.2437156.
• Rossi F, Pini R, Menabuoni L, Mencucci R, Menchini U, Ambrosini S, Vannelli G. Experimental study on the healing process following laser welding of the cornea. J Biomed Opt. 2005 Mar-Apr;10(2):024004. doi: 10.1117/1.1900703.
• Menabuoni L, Canovetti A, Rossi F, Malandrini A, Lenzetti I, Pini R. The 'anvil' profile in femtosecond laser-assisted penetrating keratoplasty. Acta Ophthalmol. 2013 Sep;91(6):e494-5. doi: 10.1111/aos.12144. Epub 2013 Apr 26. No abstract available.
• Matteini P, Rossi F, Menabuoni L, Pini R. Microscopic characterization of collagen modifications induced by low-temperature diode-laser welding of corneal tissue. Lasers Surg Med. 2007 Aug;39(7):597-604. doi: 10.1002/lsm.20532.

Helpful Links

• Information about the Ophthalmology Department of the Prato Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: May 30, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (Estimate): June 25, 2014

Study Record Updates

• Last Update Posted (Estimate): June 25, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: femtosecond laser; penetrating keratoplasty; anvil-shaped corneal graft; laser welding
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Opacity; Keratoconus; Corneal Dystrophies, Hereditary
• Other Study ID Numbers: MIL-PO-001