Pilot Study: Femtolaser Keratoplasty vs. Conventional Keratoplasty
Research type
Research Study
Full title
Pilot Study of Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty
IRAS ID
247401
Contact name
Parwez Hossain
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 10 days
Research summary
This pilot study will compare an anticipated minimum of 5 patients undergoing femtolaser assisted keratoplasty (using CE approved femtolaser apparatus) with an anticipated minimum of 5 patients undergoing conventional keratoplasty with a manual trephine. Patients will be randomly assigned to either group. The following aims of our research is detailed below:
1- Does femtosecond laser assisted keratoplasty ( FLAK ) yield faster visual recovery and better long term BCVA?
2- Does FLAK offer a biomechanically stronger cornea and thereby more safety and less risk of wound dehiscence?
3- Is there any difference between FLAK and conventional keratoplasty in terms of graft failure or rejection?Follow up in best corrected visual acuity, various refraction/astigmatism measurements, intraocular pressure, graft rejection/failure rates, pachymetry and corneal hysteresis and resistance factor will be recorded at 1 day, 1 week, 1, 3 and 6 months and 1 year and 18 months postoperatively.
Given this study is a pilot study, it has a further role in allowing us to assess the feasibility of doing this study on a larger scale. This pilot study will help us qualitatively analyse the organisational aspects of an initiative like this and also give us statistical information that would help in sample size considerations of a future, larger study.
This study, to our knowledge will be the first to provide an empirical measurement to biomechanical stability of the cornea with the femtolaser, the first randomised study comparing femto-DALK to conventional DALK, and the first done in an NHS setting.
REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/2077
Date of REC Opinion
28 Jan 2019
REC opinion
Further Information Favourable Opinion