Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty

Pilot Study of Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty

This pilot study will compare upto 15 patients undergoing femtolaser assisted keratoplasty (using CE[Conformité Européene] approved femtolaser apparatus) with upto 15 patients undergoing conventional keratoplasty with a manual trephine. Patients will be randomly assigned to either group. All keratoplasties will be penetrating keratoplasties. The following aims of this research is detailed below:

1. Does femtosecond laser assisted keratoplasty ( FLAK ) yield faster visual recovery and better long term BCVA (Best Corrected Visual Acuity)?
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.

This study, to the investigators' knowledge will be the first randomised controlled trial in this area, the first to provide an empirical measurement to biomechanical stability of the cornea with the femtolaser, and the first done in an NHS (National Health Service) setting.

Study Overview

• Status: Unknown
• Conditions: Keratoconus; Fuchs Dystrophy; Corneal Disease
• Intervention / Treatment: Procedure: Trephine blade; Procedure: Femtosecond Laser

Detailed Description

Introduction The femtosecond laser has had a profound effect on refractive surgery and, more recently, on cataract surgery and cornea transplantation. The superior precision and control offered by femtosecond laser and its potential use in cornea transplantation show promise in terms of wound stability and strength.

By doing this research project the investigators aim to answer the following questions:

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?

There have been other studies that have compared femtolaser to the manual trephine in corneal transplant keratoplasty surgery. The investigators' study, to their knowledge, will be the first randomised controlled trial in this area. The majority of interventional studies comparing the two procedures are retrospective case controls. This study, will also be the first to provide an empirical measurement to the biomechanical stability of corneas that have undergone femtolaser corneal transplant. Although theorised to be better with the femtolaser, there has yet to have been a comparative study that has utilised quantitative evidence supporting this. By measuring postoperative corneal hysteresis and corneal resistance factor using an ocular response analyser, the investigators hope to be able to do that.

Recruitment, inclusion/exclusion and method Patients attending the cornea firm at the eye unit in University Hospitals Southampton who are indicated for penetrating keratoplasty as a result of corneal disease or pathology will be recruited. The participants have no connection to the university or the researcher that is known before the research starts. The aim for this study is to have a minimum of 10 patients recruited altogether and a maximum of 30.

Inclusion criteria: • Eyes with corneal opacities owing to previous corneal pathology.

Exclusion criteria: • Eyes with concomitant ocular pathology which may affect visual acuity.

• Eyes who received previous corneal grafts. Only after the patient has given their informed consent and confirmation that they meet the criteria will they be formally included in the study.

After inclusion in the study participants will be randomised into two groups of equal numbers to either undergo femtolaser-assisted penetrating keratoplasty or to undergo conventional keratoplasty. Other than the use of instrument to make incisions for the graft on the host cornea, all other aspects of the surgery will be kept as homogenous as possible.

Patients will stay overnight or have this operation done as a day case depending on time of day the operation is done. They will then be followed up at 1 day, 1 week, 1 months, 3 months, 6 months, 12 months and 18 months in various different visual outcome measurements as well as biomechanical measures of corneal healing. The two groups will be statistically compared at each timepoint.

This study also has a further role as a pilot study to assess the feasibility of doing a study like this on a larger scale, as a randomised, controlled trial.

Consent Patients who are deemed to not have capacity will not be eligible for this study as they cannot proceed with the consent form. All staff involved in the study have appropriate training in how to judge capacity.

For those with capacity, they will read the patient information sheet first. The patient information sheet contains in layman's terms full details for potential research participants, covering issues from why the researchers are doing the study, what the researchers expect from them, the possibility of adverse effects and anonymity and confidentiality. If patients are still interested after that they will receive a consent form to be signed by them. They will be given a copy of the signed consent form to keep.

Risks, burdens and benefits Risks are explained in the patient information sheet so patients have a fully informed decision about whether to take part in the study. From the investigators point of view it is important to note these patients for this study are indicated for corneal transplant surgery - that is it is felt the benefits of a conventional surgery outweighs the normal risks of corneal transplant surgery. Femtolaser keratoplasty is not known to add any risks that is not present in conventional keratoplasty. It is CE approved for the use in creating cuts in the cornea, as the surgeons are doing for corneal transplants.

Confidentiality The nature of this study means that their details will be known to the surgeons and staff performing the surgery in data collection but these will be coded/anonymised for members of the team involved in other parts of the study, leaving the number of people who know linking details to a minimum. Any documents linking the patient's details to the code will only be the responsibility of the surgeons and their staff. The consent forms themselves will be kept inside a locked storage unit in the Southampton Eye Unit. The patients will be reassured their personal details will not be known to any of the researchers other than the surgeons and their staff that will carry out the surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Parwez N Hossain, MB ChB, PhD; Phone Number: 02381204270; Email: P.N.Hossain@soton.ac.uk

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Recruiting
      • Southampton Eye Unit
      • Contact: Parwez Hossain, MhCHb, PhD; Phone Number: 02381204270; Email: P.N.Hossain@soton.ac.uk
      • Principal Investigator: Parwez Hossain, MhCHb, PhD
      • Sub-Investigator: Joshua Adeyoju, Student
      • Sub-Investigator: Omar El-Haddad, Corneal Research Fellow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eyes with corneal opacities owing to previous corneal pathology.

Exclusion Criteria:

• Eyes with concomitant ocular pathology which may affect visual acuity.
• Eyes who received previous corneal grafts.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional keratoplasty group (Control); This group will undergo conventional penetrating keratoplasty with a trephine blade.	Procedure: Trephine blade; A trephine blade will be used to make incisions in the cornea for the graft
EXPERIMENTAL: Femtolaser group; This group will undergo femtosecond laser-assisted penetrating keratoplasty.	Procedure: Femtosecond Laser; The laser will be used to make incisions in the cornea for the graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity	Measure of clarity of vision	Followed up periodically for upto 18 months
Subjective refraction	A measure of refractive error	Followed up periodically for upto 18 months
Intraocular pressure	Fluid pressure inside the eye	Followed up periodically for upto 18 months
Corneal hysteresis	Measure of biomechanical stability of the cornea. Will be done by one machine (Ocular Response Analyser)	Followed up once at 3 months
Corneal topography	A visual outcome measure assessing corneal curvature. Will be done using a pentacam.	Followed up periodically for upto 18 months
Endothelial cell density	A measure of healing in the new graft	Followed up periodically for upto 18 months
Corneal Resistance Factor	Measure of biomechanical stability of the cornea. Will be done by one machine (Ocular Response Analyser)	Followed up once at 3 months
Keratometry	A visual outcome measure assessing corneal curvature. Will be done using a pentacam.	Followed up periodically for upto 18 months
Pachymetry	A visual outcome measure assessing corneal thickness. Will be done using a pentacam,	Followed up periodically for upto 18 months
Corneal irregularity index	A visual outcome measure assessing corneal curvature. Will be done using a pentacam.	Followed up periodically for upto 18 months
Astigmatism	A visual outcome measure assessing corneal curvature. Will be done using a pentacam.	Followed up periodically for upto 18 months

Collaborators and Investigators

• Sponsor: University of Southampton
• Investigators: Principal Investigator: Parwez Hossain, B ChB, PhD, University of Southampton

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ANTICIPATED): December 26, 2021
• Study Completion (ANTICIPATED): December 26, 2021

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (ACTUAL): August 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Laser; Corneal Transplant; Keratoplasty; Femtolaser; Corneal Graft; Trephine
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Dystrophies, Hereditary; Keratoconus; Corneal Diseases; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: 32158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No