CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Penetrating keratoplasty +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02173847
NCT02173847N/ACompleted

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

Ospedale Santo Stefano·interventional·Posted Jun 25, 2014·Updated Jun 25, 2014

In Brief

A clinical study evaluating Penetrating keratoplasty, Femtosecond laser, and 1 other intervention for Keratoconus and 2 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 25, 2014
Enrollment StartJan 1, 2011
Primary CompletionJan 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.0 years ago

Interventions

Penetrating keratoplastyprocedure

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