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55 active trials for Keratoconus

Comparison of Standard vs. Accelerated Corneal Crosslinking

The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.

Start: April 2019

Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus

Drug delivery platforms are an innovative exciting advancement in ophthalmology. They allow patients to eliminate topical medications which are generally associated with lack of compliance, difficulty of use and requiring help from family members. These delivery systems can be applied easily in office, and patients do not have to worry about drop insertion in their post-operative regimen. The results of this research project should help to answer the following question: Does the use of a physician administered intracanalicular dexamethasone insert improve the signs and symptoms of ocular allergy and dry eye disease in KC patients compared to the use of topical loteprednol etabonate ophthalmic gel 0.38%?

Start: September 2020

Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions

Start: February 2021

Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting

EYEdeal Scanning Technology enables rapid measurement of corneal and scleral topography. By accurately measuring the ocular surface with this imaging technology, the current iterative fitting method required to fit PROSE (prosthetic replacement of the ocular surface ecosystem) devices could be replaced and/or strengthened with a more rapid, automated fitting sequence. This could considerably reduce the time needed per visit, the number of visits, and the number of devices needed to be manufactured to reach the endpoint. Additionally, the scanning technology may afford the opportunity to successfully fit some pathology that were previously treatment failures. The automated technology may as well reduce the intensive clinician training time needed to fit PROSE devices, therefore increasing the availability and access to patients. The goal of this research is to evaluate the reliability and efficacy of this automated technology for fitting PROSE devices. Data from real-time measurement of the human eye ocular surface topography will be used to fabricate a prosthetic lens. The fit of the PROSE device will be evaluated, as well as the subjective comfort of the fit.

Start: December 2020

Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions

Start: January 2020

Intacs for Keratoconus

The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters). Additional clinical data have shown that INTACS are safe for the treatment of keratoconus, in July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian Use Device (FDA approval letter attached). The statute and the implementing regulation of FDA (21 CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS prescription inserts are composed of two clear segments, each having an arc length of 150°, they are manufactured form a biomedical material called polymethylmethacrylate (PMMA) and are available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may be implanted depending on the orientation of the cone and the amount of myopia and astigmatism to be reduced.

Start: January 2011

Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions

To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients with corneal thinning conditions.

Start: July 2020

Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus

This is a prospective, Phase I open-label safety study to evaluate the safety, feasibility and initial efficacy of a bioengineered corneal stromal substitute after implantation into the stroma of adults with advanced keratoconus. The bioengineered substitute and implantation technique may provide a less invasive treatment option for advanced keratoconus than current surgical approaches, that additionally does not rely on the limited availability of human donor corneal tissue.

Start: May 2016

The Role of Antioxidant Supplementation in Keratoconus Patients

Keratoconus is the most common primary cornea ectasia, where the cornea undergoes structural changes, leading to loss of tissue integrity and vision loss. The prevalence of Keratoconus is 1:2000 in the general population. Oxidative stress has been thought to have a major effect in the disease pathogenesis of Keratoconus. In vitro studies have shown increase in metabolites related to oxidative stress in Keratoconus disease, and that Keratoconus cells undergo increased oxidative stress and tissue damage. Animal models have shown a therapeutic effect of Vitamin C (ascorbate) in corneal wound healing. Glutathione and Vitamins A, C, and E are important antioxidants in the human body. To this date, the role of systemic antioxidant supplementation in Keratoconus patients has yet to be studied. In addition, it has yet to be established as to whether there is a correlation between serum antioxidant levels, and the severity of disease in the Keratoconus patient. The investigators propose to investigate the plasma levels of antioxidants in relation to disease severity. The investigators will also investigate the role of antioxidant supplementation-consisting of parenteral Glutathione (GSH), and Vitamins A, C and E-in delaying the disease progression in Keratoconus.

Start: August 2021

Keratoconus, Corneal Diseases and Transplant Registry

The cornea is the clear layer in front of the iris and pupil. It protects the iris and lens and helps focus light on the retina. Corneal diseases are serious conditions that can cause clouding, distortion, scarring and eventually blindness. There are several types of corneal disease with keratoconus being one of the most prominent. Keratoconus is a weakening and thinning of the central cornea. This thinking causes the cornea to develop a cone-shaped deformity leading to vison loss. Keratoconus is usually bilateral affecting people between 10 and 25. This project aims to collect data on patient suffering with corneal diseases and the treatments they receive, including corneal transplantation, over a period of time during routine clinical practice. A clinical registry such as this can be a very useful tool to provide a real-world view of clinical practice, patient outcomes, safety, and comparative effectiveness. •Methods: Data will be collected from the medical records of patients who have suffered from corneal disease and have undergone treatment in the Ophthalmology department of the CHU Montpellier. A standardized set of data will be collected for all patients. This will include, demographic and social date such as lifestyle and occupation, current and past pathologies and treatment received. This is data that is already collected as part of routine clinical practice. This will be an ongoing registry with the aim of collecting the maximum data possible. The more patients that are entered and the longer the follow up for each patient, the more valuable the data will become. •Discussion: The aim of this registry to help create a better understanding of variations in treatment and outcomes; to examine factors that influence prognosis; to describe treatment patterns, including appropriateness and effectiveness of treatment and disparities in the delivery of care; to monitor safety and harm and to measure quality of care. In the long term the data collected in the registry may serve as a basis for the development of evidence-based clinical management guidelines to help clinicians deliver the most appropriate treatment for corneal diseases in the safest and most efficient manner.

Start: December 2019

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: Does femtosecond laser assisted keratoplasty ( FLAK ) yield faster visual recovery and better long term BCVA (Best Corrected Visual Acuity)? Does FLAK offer a biomechanically stronger cornea and thereby more safety and less risk of wound dehiscence? 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.

Start: February 2019

Epi-on PiXL for the Treatment of Progressive Keratoconus.

The purpose of this study is to evaluate the efficacy, safety and postoperative ocular discomfort by individually customized Photorefractive intrastromal crosslinking (PiXL) without epithelium debridement in high oxygen environment (Epi-on) for progressive Keratoconus.

Start: March 2019

Photorefractive Intrastromal Crosslinking (PiXL) for the Treatment of Progressive Keratoconus

The purpose of this study is to evaluate the efficacy, safety and postoperative ocular discomfort by comparing individually customized Photorefractive intrastromal crosslinking (PiXL) for progressive Keratoconus. The study compares two different protocols, PiXL with corneal epithelium debridement (Epi-off) and PiXL without epithelium debridement in high oxygen environment (Epi-on), with the hypothesis that Epi-on gives less postoperative ocular discomfort.

Start: April 2019

The Homburg Keratoconus Center (HKC)

Aim of this study is to conduct longitudinal and cross-sectional analyses about the corneal ectatic disease Keratoconus based on data obtained from Keratoconus patients in the Homburg Keratoconus Center (HKC). The Homburg Keratoconus Center (HKC) was founded in 2010 and, up to now, comprises more than 1.200 Keratoconus patients. Topographic, tomographic and biomechanic characteristics of the disease are being analyzed with the intention to elucidate how the disease begins and develops during lifetime.

Start: January 2011

Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report

The aim of our study is to investigate the feasibility and the effect of fresh lenticule implantation as allogenic graft that will be taken from myopic patients to implant in patients with keratoconus disease using VisuMax Femtosescond laser- Smile module surgery with primary objective to increase central corneal thickness and secondary to improve visual acuity and reduces K-values and to show the autologous serum drop improve the recovery of patients with mild dry eye in keratoconus disease.

Start: May 2019

Epithelial Thickness Map

In keratoconic eyes, the corneal epithelium shows a localized thinning over the cone that is surrounded by an annulus of epithelial thickening. It has been postulated that epithelial thickness mapping can be a sensitive tool for the keratoconus diagnosis. In keratoconus screening the 5 mm diameter of the corneal centrum may be sufficient while studies have shown that the cone apex is located in this area. Aim of this study is to assess agreement and repeatability of epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas. Secondary objective is to evaluate the differences between healthy and keratoconus eyes using epithelial thickness map data. This is a prospective monocentric study that includes patients divided into two groups: patients with keratoconus and a control group formed out of patients without corneal pathologies. For each patient only one eye will be included and corneal measurements will be performed, focused on the corneal epithelium thickness.

Start: October 2020

fMRI and Cornea Microscopy of CXL

Our long-term goal is to evaluate the transition from acute to chronic pain that sometimes occurs following CXL in keratoconus patients. This study will determine whether these changes can be structurally and functionally quantified using functional neuroimaging and in vivo corneal microscopy (IVCM), and whether they can be predicted based on predisposing biological and psychological factors. Our central hypothesis is that CXL produces acute pain through activation of trigeminal afferents, and that post-operative chronic pain outcomes are related to neuroplastic changes in trigeminal circuitry, corneal afferent regeneration, and psychological factors.

Start: March 2021

Scleral Lens Fitting Using Wide-Field OCT

The purpose of this study is to see if OCT technology can optimize scleral contact lens fittings. Subjects with keratoconus, post-penetrating keratoplasty (PK), post-LASIK ectasia, post-radial keratotomy (RK), or a variety of anterior surface disorders requiring scleral lens fittings will be considered for enrollment. For each study eye, a clinically-selected scleral lens fit will be compared against an OCT-selected lens fit. The quality of each lens fit will be determined by flourescein exam at the slit lamp. Apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be assessed. A lens that satisfies all four criteria will be considered satisfactory.

Start: September 2020

Refractive Corneal Cross-linking for Progressive Keratoconus

Young patients with keratoconus face two problems: disease progression and corneal shape irregularity. Both underlie the 20% rate of corneal transplantation in keratoconics required to maintain useful vision. Corneal collagen cross-linking (CXL) is a now the gold-standard treatment to halt disease progression. The aim is to strengthen the cornea to prevent further shape deterioration. For patients whose quality of vision has already suffered, standard CXL can generally only prevent further deterioration, rather than improving vision. Refractive CXL, a new iteration of CXL in which a bespoke treatment pattern is applied to the cornea, aims to smooth out surface irregularities thereby improving vision. This primary objective of this study is to compare the visual outcome in patients with progressive keratoconus treated with refractive CXL, as compared with historical controls treated with standard CXL.

Start: November 2018

Efficacy of Customized Corneal Cross-linking vs. Standard Corneal Cross-linking

The standard or Dresden protocol was established in 2003 and treats the entire cornea. However, recent ultra-structural research showed that keratoconus is localized. Therefore, treating only the affected zone and minimalizing the risk of damaging surrounding tissues would be beneficial. The objective of this study is to evaluate whether the effectiveness of customized cross-linking (cCXL) is non-inferior to standard cross-linking (sCXL) in terms of flattening of the cornea and halting keratoconus progression.

Start: November 2020