Laser Assisted Procedures in Penetrating Keratoplasty

NCT02173847 | Completed

• 1 other identifier: MIL-PO-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Keratoconus; Corneal Dystrophies; Corneal Opacity

Keywords

anvil-shaped corneal graft; penetrating keratoplasty; femtosecond laser; laser welding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in objective astigmatism and specular corneal topography

  1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery

Other Outcomes (1)

• Change in anterior segment optical coherence tomography

  1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery

Study Arms (1)

Penetrating keratoplasty

EXPERIMENTAL

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

Interventions

Penetrating keratoplasty PROCEDURE

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

Penetrating keratoplasty

Femtosecond laser DEVICE

A commercial femtosecond laser to cut a particular shaped graft

Penetrating keratoplasty

Diode laser DEVICE

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

Penetrating keratoplasty

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• systemic diseases
• previous corneal surgery
• glaucoma

Sponsors & Collaborators

• Ospedale Santo Stefano: lead
• Istituto di Fisica Applicata: collaborator

Study Sites (1)

U.O. Oculistica Nuovo Ospedale S. Stefano

Prato, Prato, 59100, Italy

Location

Related 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.

  PMID: 24140371 BACKGROUND

• 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.

  PMID: 19343656 BACKGROUND

• 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.

  PMID: 17720078 BACKGROUND

• 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.

  PMID: 17343506 BACKGROUND

• 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.

  PMID: 15910078 BACKGROUND

• 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.

  PMID: 23617376 BACKGROUND

• 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.

  PMID: 17868101 BACKGROUND

Related Links

• Information about the Ophthalmology Department of the Prato Hospital

MeSH Terms

Conditions

Keratoconus; Corneal Dystrophies, Hereditary; Corneal Opacity

Interventions

Keratoplasty, Penetrating; Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Corneal Transplantation; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Transplantation; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Luca Menabuoni, MD

  Head of Corneal and Experimental Surgery at the Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 25, 2014
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

IT (1)