NCT03619434 is a NA clinical trial of Femtosecond Laser in Keratoconus, sponsored by University of Southampton.

Who is sponsoring NCT03619434?

NCT03619434 is sponsored by University of Southampton.

What drugs are being tested in NCT03619434?

Interventions in NCT03619434: Femtosecond Laser, Trephine blade.

What condition does NCT03619434 study?

NCT03619434 studies Keratoconus, Fuchs Dystrophy, Corneal Disease.

Is NCT03619434 still recruiting?

NCT03619434 is currently status unknown. Last updated 22 December 2020.

Last reviewed 2020-12-22 · How we verify

NCT03619434

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty

Status unknown NA Last updated 22 December 2020

What this trial tests

NA trial testing Femtosecond Laser in Keratoconus in 30 participants. Status unknown.

Timeline

1 February 2019

Primary endpoint
26 December 2021

26 December 2021

Quick facts

Lead sponsor	University of Southampton
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 February 2019
Primary completion	26 December 2021
Estimated completion	26 December 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

Femtosecond Laser
Trephine blade

Conditions studied

Keratoconus — all drugs for Keratoconus →
Fuchs Dystrophy — all drugs for Fuchs Dystrophy →
Corneal Disease — all drugs for Corneal Disease →

Sponsor

University of Southampton

Who can join

Adults 16 to 90, any sex, with Keratoconus or Fuchs Dystrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Therapeutic future of Fuchs endothelial corneal dystrophy: An ongoing way to explore.
Liu JX, Chiang TL, Hung KF, Sun YC. · · 2024 · cited 5× · PMID 38654984 · DOI 10.4103/tjo.tjo-d-23-00115

Verify or expand the search:

Other trials of Femtosecond Laser

Trials testing the same drug.

NCT04775849 — Intraoperative Berger Space Imaging (IBSI) · NA · unknown
NCT03465124 — Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery · NA · unknown

Other recruiting trials for Keratoconus

Currently open trials in the same condition.

NCT07372911 — PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus · NA · recruiting
NCT07461129 — Electrophysiological Changes in Cases of Different Stages of Keratoconus · active not recruiting
NCT06601101 — Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus · Phase 3 · recruiting
NCT05516004 — Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning · Phase 2 · recruiting
NCT06798779 — Predicting Manifest Astigmatism in Keratoconus Patients. · active not recruiting

Other University of Southampton trials

Trials by the same sponsor.

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NCT06692959 — A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer · Phase 2 · recruiting
NCT06815120 — A Novel Ureteric Stent in Kidney Stone Patients and Oncology Patients Compared to a Conventional JJ Stent · NA · not yet recruiting
NCT06566157 — PROMOTE: The Effect of a Six Week Prebiotic Supplementation on Wellbeing of Young Adults. · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03619434 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Southampton
Last refreshed: 22 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03619434.

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