Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty

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Brief Title

Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty

Official Title

Pilot Study of Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty

Brief Summary

      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.
    

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


Primary Outcome

Best Corrected Visual Acuity


Condition

Keratoconus

Intervention

Femtosecond Laser

Study Arms / Comparison Groups

 Conventional keratoplasty group (Control)
Description:  This group will undergo conventional penetrating keratoplasty with a trephine blade.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

30

Start Date

February 1, 2019

Completion Date

December 26, 2021

Primary Completion Date

December 26, 2021

Eligibility Criteria

        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.
      

Gender

All

Ages

16 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Parwez Hossain, B ChB, PhD, 02381204270, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03619434

Organization ID

32158


Responsible Party

Sponsor

Study Sponsor

University of Southampton


Study Sponsor

Parwez Hossain, B ChB, PhD, Principal Investigator, University of Southampton


Verification Date

December 2020