Laser Assisted Procedures in Penetrating Keratoplasty

NCT ID: NCT02173847

Last Updated: 2014-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-09-30

Brief 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

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.

Conditions

Keratoconus; Corneal Dystrophies; Corneal Opacity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Penetrating keratoplasty

Femtosecond laser sculptured anvil graft. Diode laser welding of the flap in its final position. 12 months follow up study

Group Type: EXPERIMENTAL

Penetrating keratoplasty

Intervention Type: PROCEDURE

Femtosecond laser sculptured anvil graft. Laser welding of the flap in its final position. 12 months follow up study

Femtosecond laser

Intervention Type: DEVICE

A commercial femtosecond laser to cut a particular shaped graft

Diode laser

Intervention Type: DEVICE

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

Interventions

Penetrating keratoplasty

Femtosecond laser sculptured anvil graft. Laser welding of the flap in its final position. 12 months follow up study

Intervention Type: PROCEDURE

Femtosecond laser

A commercial femtosecond laser to cut a particular shaped graft

Intervention Type: DEVICE

Diode laser

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• systemic diseases
• previous corneal surgery
• glaucoma

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto di Fisica Applicata

UNKNOWN

Sponsor Role: collaborator

Ospedale Santo Stefano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Menabuoni, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Corneal and Experimental Surgery at the Department of Ophthalmology

Locations

U.O. Oculistica Nuovo Ospedale S. Stefano

Prato, Prato, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 24140371 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19343656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17720078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17343506 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15910078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23617376 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17868101 (View on PubMed)

Related Links

http://www.usl4.toscana.it/?act=f&fid=758

Information about the Ophthalmology Department of the Prato Hospital

Other Identifiers

MIL-PO-001

Identifier Type: -

Identifier Source: org_study_id