ClinicalTrials.gg
CompletedNCT02173847Updated Jun 25, 2014

Laser Assisted Procedures in Penetrating Keratoplasty

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

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
16 Years to 75 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Keratoconus
  • Corneal Dystrophies
  • Corneal Opacity

Keywords

  • anvil-shaped corneal graft
  • penetrating keratoplasty
  • femtosecond laser
  • laser welding
03

In context

Keratoconus

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.

Browse Keratoconus studies →

Lead sponsor

This is the only study on the registry with Ospedale Santo Stefano as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • systemic diseases
  • previous corneal surgery
  • glaucoma
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • 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 · Device: Femtosecond laser · Device: Diode laser

Interventions

  • ProcedurePenetrating keratoplasty

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

  • DeviceFemtosecond laser

    A commercial femtosecond laser to cut a particular shaped graft

  • DeviceDiode laser

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

07

Study locations

1 site
  • U.O. Oculistica Nuovo Ospedale S. Stefano
    Prato, 59100, Italy
08

References and documents

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. PubMed 24140371 ↗
  • 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. PubMed 19343656 ↗
  • 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. PubMed 17720078 ↗
  • 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. PubMed 17343506 ↗
  • 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. PubMed 15910078 ↗
  • 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. PubMed 23617376 ↗
  • 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. PubMed 17868101 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

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.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2014
First posted
Jun 25, 2014
Start
Jan 2011
Primary completionActual
Jan 2013
CompletionActual
Sep 2013
Last update
Jun 25, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02173847
Lead sponsor
Ospedale Santo Stefano
Collaborators
Istituto di Fisica Applicata
Responsible party
Sponsor
First posted
Jun 25, 2014
Start date
Jan 2011
Primary completion
Jan 2013
Completion
Sep 2013
Last update
Jun 25, 2014

Study contacts

Luca Menabuoni, MD
principal investigator · Head of Corneal and Experimental Surgery at the Department of Ophthalmology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion