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Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty

NCT03619434 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-12-22

No results posted yet for this study

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.

Conditions

  • Keratoconus
  • Fuchs Dystrophy
  • Corneal Disease

Interventions

PROCEDURE

Femtosecond Laser

The laser will be used to make incisions in the cornea for the graft.

PROCEDURE

Trephine blade

A trephine blade will be used to make incisions in the cornea for the graft

Sponsors & Collaborators

  • University of Southampton

    lead OTHER

Principal Investigators

  • Parwez Hossain, B ChB, PhD · University of Southampton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2021-12-26
Completion
2021-12-26

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03619434 on ClinicalTrials.gov