Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty

NCT03619434 | Unknown

• 1 other identifier: 32158
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Does femtosecond laser assisted keratoplasty ( FLAK ) yield faster visual recovery and better long term BCVA (Best Corrected Visual Acuity)?
2. 2.Does FLAK offer a biomechanically stronger cornea and thereby more safety and less risk of wound dehiscence?
3. 3.Is there any difference between FLAK and conventional keratoplasty in terms of graft failure or rejection?

Conditions

Keratoconus; Fuchs Dystrophy; Corneal Disease

Keywords

Femtolaser; Corneal Transplant; Keratoplasty; Corneal Graft; Laser; Trephine

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

Conventional keratoplasty group (Control)

ACTIVE COMPARATOR

This group will undergo conventional penetrating keratoplasty with a trephine blade.

Procedure: Trephine blade

Femtolaser group

EXPERIMENTAL

This group will undergo femtosecond laser-assisted penetrating keratoplasty.

Procedure: Femtosecond Laser

Interventions

Femtosecond Laser PROCEDURE

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

Femtolaser group

Trephine blade PROCEDURE

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

Conventional keratoplasty group (Control)

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eyes with corneal opacities owing to previous corneal pathology.

You may not qualify if:

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

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

Southampton Eye Unit

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Keratoconus; Fuchs' Endothelial Dystrophy; Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Corneal Dystrophies, Hereditary; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Parwez Hossain, B ChB, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Parwez N Hossain, MB ChB, PhD

CONTACT

02381204270; P.N.Hossain@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking as the investigators are assessing differences in surgical technique
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective cohort study where a maximum of 30 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. All patients will receive a complete ophthalmological examination preoperatively. Subjects will then be divided randomly into 2 groups of 15, should we get 30 patients;

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 7, 2018
• Study Start: February 1, 2019
• Primary Completion: December 26, 2021
• Study Completion: December 26, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

GB (1)