Laser Assisted Procedures in Penetrating Keratoplasty

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173847
• Other study ID #: MIL-PO-001
• Status: Completed
• Phase: N/A
• First received: May 30, 2014
• Last updated: June 23, 2014
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: June 2014
• Source: Ospedale Santo Stefano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• Corneal dystrophy

• keratoconus in its final stages

• post-herpetic leukoma

• corneal scar

Exclusion Criteria:

• systemic diseases

• previous corneal surgery

• glaucoma

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Dystrophies
• Corneal Opacity
• Keratoconus

Intervention

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
• Diode laser
Low power, near infrared diode laser for welding the surgical wound

Locations

Country	Name	City	State
Italy	U.O. Oculistica Nuovo Ospedale S. Stefano	Prato

Sponsors (2)

Lead Sponsor	Collaborator
Ospedale Santo Stefano	Istituto di Fisica Applicata

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No

External Links

•   Information about the Ophthalmology Department of the Prato Hospital
•   Research group description developing new laser based surgical approaches. The group is part of the Italian National Research Council, Institute of Applied Physics