KeratoconusNCT02173847
Laser Assisted Procedures in Penetrating Keratoplasty
A study testing Penetrating keratoplasty, Femtosecond laser and Diode laser in people with Keratoconus and Corneal Dystrophies, run by Ospedale Santo Stefano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Keratoconus, Corneal Dystrophies, Corneal Opacity
- What is being tested?
- Penetrating keratoplasty, Femtosecond laser and Diode laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Corneal dystrophy
- keratoconus in its final stages
- post-herpetic leukoma
- corneal scar
Who cannot join
- systemic diseases
- previous corneal surgery
- glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Keratoconus, Corneal Dystrophies, Corneal Opacity
- Being tested
- Penetrating keratoplasty, Femtosecond laser, Diode laser
- Keywords
- anvil-shaped corneal graft, penetrating keratoplasty, femtosecond laser, laser welding
- Medical subject headings
- Keratoconus, Corneal Dystrophies, Hereditary, Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penetrating keratoplastyProcedure or surgery
Femtosecond laser sculptured anvil graft. Laser welding of the flap in its final position. 12 months follow up study
Femtosecond laserDevice
A commercial femtosecond laser to cut a particular shaped graft
Diode laserDevice
Low power, near infrared diode laser for welding the surgical wound
| Study group | Role | What they receive |
|---|---|---|
| Penetrating keratoplasty | Experimental | Femtosecond laser sculptured anvil graft. Diode laser welding of the flap in its final position. 12 months follow up study Receives: Procedure: Penetrating keratoplasty; Device: Femtosecond laser; Device: Diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best spectacle-corrected distance visual acuity (CDVA)
documentation of the visual acuity of patients
Measured: 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
Measured: 1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Santo Stefano
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto di Fisica Applicata
- Responsible party
- Sponsor
- Investigators
- Luca Menabuoni, MD, Principal investigator, Head of Corneal and Experimental Surgery at the Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173847
- Sponsor's protocol ID
- MIL-PO-001
- Status last verified
- Jun 2014
- First submitted
- 30 May 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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 24140371Rossi 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 19343656Menabuoni 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 17720078Rossi 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 17343506Rossi 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 15910078Menabuoni 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 23617376Matteini 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Assisted Procedures in Penetrating Keratoplasty: Femtosecond Laser Anvil-shaped Cuts and Laser Welding of the Surgical Wounds
- ClinicalTrials.gov ID
- NCT02173847
- Acronym / sponsor ID
- MIL-PO-001
- Conditions
- Keratoconus, Corneal Dystrophies, Corneal Opacity
- Keywords
- anvil-shaped corneal graft, penetrating keratoplasty, femtosecond laser, laser welding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ospedale Santo StefanoUniversity, hospital or other
- Collaborators
- Istituto di Fisica Applicata
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penetrating keratoplasty | Experimental | Procedure: Penetrating keratoplasty, Device: Femtosecond laser, Device: Diode laserFemtosecond laser sculptured anvil graft. Diode laser welding of the flap in its final position. 12 months follow up study |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Corneal dystrophy
- keratoconus in its final stages
- post-herpetic leukoma
- corneal scar
Key exclusion criteria (3 listed)
- systemic diseases
- previous corneal surgery
- glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penetrating keratoplastyFemtosecond laser sculptured anvil graft. Laser welding of the flap in its final position. 12 months follow up study | Procedure or surgery | Penetrating keratoplasty |
| Femtosecond laserA commercial femtosecond laser to cut a particular shaped graft | Device | Penetrating keratoplasty |
| Diode laserLow power, near infrared diode laser for welding the surgical wound | Device | Penetrating keratoplasty |
Primary outcome
Change in best spectacle-corrected distance visual acuity (CDVA)
Time frame: 1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery
documentation of the visual acuity of patients
1 secondary outcome
Change in objective astigmatism and specular corneal topography
Time frame: 1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Background: PubMed 24140371Buzzonetti 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.
- Background: PubMed 19343656Rossi 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.
- Background: PubMed 17720078Menabuoni 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.
- Background: PubMed 17343506Rossi 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.
- Background: PubMed 15910078Rossi 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.
- Background: PubMed 23617376Menabuoni 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.
- Background: PubMed 17868101Matteini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Menabuoni, MD principal investigator
Head of Corneal and Experimental Surgery at the Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penetrating keratoplasty, Femtosecond laser and Diode laser in people with Keratoconus and Corneal Dystrophies, run by Ospedale Santo Stefano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in best spectacle-corrected distance visual acuity (CDVA) (time frame: 1 day, 7 days, 1 month, 3 months, 6 months, and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02173847, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2014.