Evaluation of Tomographic and Genetic Aspects of Keratoconus Patients Compared to Sounds Corneas

Learn more about:
Related Access Program
Related Clinical Trial
Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning PXL-Platinum 330 in Eyes With Corneal Thinning Conditions Theranostic Guided Riboflavin/UV-A Corneal Cross-linking Cyanocobalamin as Photosensitizing Agent Evaluation Of Deep Anterior Lamellar Keratoplasty By Anterior Segment Ocular Coherence Tomography Autologous Adipose-Derived Adult Stem Cell Implantation for Corneal Diseases (ADASCs-CT-CD) Safety and Preliminary Efficacy of IVMED-80 Eye Drops in Keratoconus Patients Assessment of Corneal Stiffness in Keratoconus After Crosslinking by Corvis ST and OCT. Customized Contact Lenses Correlation Between Q-value Changes and Progression of Pediatric Keratoconus. Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS Initial Correction Keratoconus Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose Gamma-Irradiated Corneal Inlay for Keratoconus Transepithelial Customized Cross-linking The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus Investigator Initiated, Prospective Study of Xenia Corneal Lenticule Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution Epi-on PiXL for the Treatment of Progressive Keratoconus. Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus Corneal Biomechanical Analysis Using Brillouin Microscopy Fresh Corneal Lenticule Implantation and Autologous Serum – Case Report Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery Safety and Efficacy of Ex Vivo Corneal Cross-Linking of Donor Corneal Tissue Used For a Penetrating Keratoplasty Epithelial Thickness Map Scleral Lens Fitting Using Wide-Field OCT Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus. Efficacy of Customized Corneal Cross-linking vs. Standard Corneal Cross-linking Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC) Endothelial Cell Loss After Penetrating Keratoplasty Corneal Tomographic Parameters in TGD fMRI and Cornea Microscopy of CXL Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas Retrospective Observational Study of Posterior Keratometry Measured Safety and Efficacy of an Intracanalicular Dexamethasone Insert Compared to Topical Loteprednol Etabonate Ophthalmic Gel 0.38% in Patients With Keratoconus Wearing Rigid Gas Permeable Contact Lenses Who Have Been Diagnosed With Allergic Conjunctivitis Safety and Effectiveness of the PXL-Platinum 330 System Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas Impact of Cataract Surgery on Keratoplasty Graft Survival Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution Comparison Between Standard Deep Anterior Lamellar Keratoplasty (S-DALK) and Intralase Enabled Deep Anterior Lamellar Keratoplaty (IE-DALK) Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone : Tolerance and Safety Pilot Study Laser Assisted Procedures in Penetrating Keratoplasty Changes of Visual Function, Ocular Surface Structures and Physiology After Long-Termed Contact Lens Wear Clinical and Structural Outcome of Conventional Versus Accelerated Corneal Collagen Cross-linking (CXL). Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases Long Term Cornea Graft Survival Study Clinical Study – ES 900 – 2020-2 – Extended Corneal Topography Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty Corneal Cross Linking and Topography Guided Excimer Laser Treatment Corneal Elastography and Patient Specific Modeling Comparison of WaveLight Analyzer and Alcon LadarWave Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions Corneal Thickness Changes With Scleral Contact Lenses A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN Corneal Uptake of Riboflavin Eye Drops Accelerated Corneal Cross-linking With Different Riboflavin Solutions Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking Changes in the Tear Film With Scleral Contact Lens Wear for Keratoconic Eyes Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin Corneal Transplantation Guided by OCT RESCAN Lamellar Transplant With Lyophilized Corneas CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2) Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia Evaluation of the Keratoconic Cornea After Corneal Collagen Cross Linking. A Study to Test the Potential of Brillouin Microscopy for Biomechanical Properties Measurements in Human Cornea Biomechanical Properties of Keratoconic Eyes A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz Tonometer Evaluating Collagen Cross-Linking (CCL) Treatment in Norway Deep Anterior Lamellar Keratoplasty (DALK) Central Versus Peripheral Air Injection for DALK (Deep Anterior Lamellar Keratoplasty) Femtosecond Laser-Assisted Keratoplasty Femtosecond Laser-assisted Anterior Lamellar Keratoplasty Investigation of Different Scanning Protocols for 3 Dimensional High-resolution Imaging of the Human Cornea With Optical Coherence Tomography (OCT) – A Pilot Study CEI Van Outreach Screening Study Dresden Corneal Disease and Treatment Study Corneal Topographer Fluorescein Patterns German Corneal Cross Linking Register Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2 Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking Corneal Biomechanical Changes of Allergic Conjunctivitis Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas Scleral Versus Corneal RGP Contact Lenses in Irregular Cornea Disorders Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up. Comparison of Standard vs. Accelerated Corneal Crosslinking OCT-guided LALAK for KCN Femtosecond Laser Assisted Keratoplasty Impact of Scleral Contact Lens Wear on Corneal Nerves in Keratoconus Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution OCT McNeel Eye Center Corneal Crosslinking Study OCT in Diagnosis of Irregular Corneas The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia Myoring Versus Keraring Implantation for Keratoconus Objective and Subjective Diagnostic Parameters in the Fellow Eye of Unilateral Keratoconus Correlation Between Eye Rubbing and Keratoconus Severity in a Treatment-naive Keratoconic Population Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs T-Cat Laser & Cross-linking for Keratoconus Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus Comparison of Anwar and Melles Techniques in Deep Anterior Lamellar Keratoplasty (DALK) for Keratoconus Patients Keratoconus, Corneal Diseases and Transplant Registry Photorefractive Intrastromal Crosslinking (PiXL) for the Treatment of Progressive Keratoconus Corneal Collagen Cross-Linking (CXL) Performed With “Epi-ON” Versus “Epi-OFF” in Eyes With Keratoconus and Other Corneal Ectatic Disorders Simultaneous TransPRK and Corneal Collagen Cross-Linking Safety and Effectiveness of Corneal Crosslinking (CXL): Keratoconus and Post-Refractive Ectasia Standard Versus Transepithelial Corneal Crosslinking Agreement and Accuracy of Different Devices Corneal Measurements Cross-Linking ACcéléré Iontophorèse Confocal kératocONE Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus Progressive Keratoconus or Ectasia Treatment Plan Higher Irradiance in Keratoconus Ectasia The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial A Clinical Study of Keratoconus in Asian Patients and Assessment of Different Topographic Patterns of Keratoconus in Asian Patients KERatoconus and Metalloproteinases InvesTigation The K-Map Study, Global Prevalence of KC Safety and Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia Comparison of Partial Removal and Total Removal of the Corneal Epithelium on Keratoconus Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Corneal Ring Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus. CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia Evaluating the Safety and Efficacy of the KXL System for Corneal Collagen Cross-Linking in Eyes Having Keratoconus Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin Adapted Fluence Settings for Corneal Collagen Cross-linking in Mild to Moderate Progressive Keratoconus Refractive Corneal Cross-linking for Progressive Keratoconus Reliability of Topography Measurements in Keratoconus Feasibility Study of the Vedera KXS for Treatment of Keratoconus Safety Study of the VEGA UV-A System to Treat Keratoconus The Possible Role of Thyroxine in Keratoconus Development Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients Intraestromal Corneal Ring in Mild Keratoconus Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye Refractive Treatment of Early Keratoconus Keratoconus – Biomarkers and Questionnaire Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus Combined Corneal Wavefront-guided TPRK and ACXL Following ICRS Implantation in Management of Moderate Keratoconus Riboflavin at 4ºC for the Management of Pain After Crosslinking for Keratoconus Patients Treatment of Keratoconus Using Collagen Cross-Linking Microwave Treatment and Corneal Collagen Crosslinking for Keratoconus Familial Analysis of Keratoconus Risk Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update. PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus Corneal Biomechanical Properties and Anterior Segment Parameters, in Forme Fruste Keratoconus Collagen Cross-linking in Keratoconus Tobacco Smoking Among Crosslinked-keratoconus Patients Treatment of Keratoconus With Advanced CXL-II MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus Astigmatic Vector Analysis of Posterior Cornea – a Comparison Among Healthy, Forme Fruste and Overt Keratoconus Corneas Management of Patients With Keratoconus With Intacs Collagen Crosslinking for Keratoconus – a Randomized Controlled Clinical Trial Corneal Tissue Inlay for Keratoconus The Role of Antioxidant Supplementation in Keratoconus Patients Epi-On Corneal Crosslinking for Keratoconus Treatment of Keratoconus With PALK Versus PK Conventional Collagen Crosslinking in Young Keratoconus Corneal Sensitivity Cross-linking Keratoconus Corneal Epithelial and Stromal Thickness Distribution in Keratoconus Treatment of Keratoconus With Advanced Corneal Crosslinking Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus Corneal Stroma Implantation for the Treatment of Keratoconus Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus Stromal Enhancement in Keratoconus, Using Stromal Lenticules of Myopic SMILE Patients (Simultaneously) Transepithelial Corneal Collagen Crosslinking in Eyes With Progressive Keratoconus Prevalence of Keratoconus in Inflammatory Bowel Diseases Keratoconus Detection by Ultrasound Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus Variability of Pentacam-derived Back Elevation Measurements in Keratoconus and Cross-linked Corneas Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus Eye Rubbing and Keratoconus in Montpellier CHU Orthokeratology for Keratoconus Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus Intacs for Keratoconus Intacs for Keratoconus The Homburg Keratoconus Center (HKC) Evaluation of Tomographic and Genetic Aspects of Keratoconus Patients Compared to Sounds Corneas Prevelance of Keratoconus Astigmatism in Keratoconus Patients Measurement of High Order Aberrations in Late Stages Keratoconus Retrospective Digital Computer Analysis of Keratoconus Evolution – REDCAKE Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus Identification and Validation of Functional Biomarkers for Keratoconus

Brief Title

Evaluation of Tomographic and Genetic Aspects of Keratoconus Patients Compared to Sounds Corneas

Official Title

Evaluation of Tomographic and Genetic Aspects of Keratoconus Patients Compared to Sounds Corneas

Brief Summary

      Evaluation of tomographic (Pentacam) parameters and genetic parameters of Visual System
      Homeobox 1 (VSX1), Superoxide Dismutase (SOD1), Tissue Inhibitors of Metalloproteinases
      (TIMP3) genes of keratoconus patients diagnosed by clinical exam and topographic pattern.
      Basically we are screening patients that don't have keratoconus that those have keratoconus.
      The pentacam index of corneal curvature, thinnest point, corneal high order aberrations,
      posterior and anterior elevation, corneal densitometry, corneal volume were investigated. To
      analyze the genes, we took corneal epithelium samples of patients submitted to cross linking
      compared to (PRK) Photo Refractive Keratectomy ones. Also will be evaluated the genes of
      peripheral blood.
    

Detailed Description

      Keratoconus is a common disease that affects the cornea in both genders in all ethnic groups
      and that can manifest unilaterally or bilaterally in patients. Keratoconus due to a
      degenerative disease, its progression can be fast in various situations, affecting 1 in every
      2,000 people, what results in severe structural changes of the cornea, which reduces its
      thickness and modify its normal curvature to a more conical shape. Keratoconus arises in
      adolescence and lasts for thirty to forty years of age, where it stabilizes and it is
      considered a major cause of corneal transplantation. Factors such as atopy, overuse of
      contact lenses and the act of rubbing the eyes are also related to the disease. The clinical
      picture consists of a lot of varied symptoms and it depends on the stage of disease
      progression. Currently it is known that genetic and environmental factors are involved in the
      desease emergence. Recently several genetic studies have aimed to identify mutations in genes
      which are directly linked to Keratoconus, such as VSX1, SOD1 and TIMP3 genes. However,
      despite the efforts directed towards the understanding of the genetic aspects of this
      disease, involving many genes, there are still many questions about the role of these genes
      in Keratoconus etiology. Thus, the present study aims to identify the presence of mutations
      in VSX1, SOD1 and TIMP3 genes, which are considered important candidates for the origin and
      development of this eye anomaly, through the analysis of their nucleotide sequences in
      corneal tissue and peripheral blood in Keratoconus patients, in their unilateral and
      bilateral forms. The results will allow to compare the presented mutations in different
      analysed tissues for unilateral and bilateral forms of Keratoconus and also compare them with
      the same tissues in healthy patients, in an attempt to establish what the likely inherited
      and/or acquired genetic mutations are causing this condition. Thus providing genetic data,
      still unpublished in Brazilian populations, which may offer subsidies for the
      characterization of the mutation dynamics and their patterns, on the origin and development
      of Keratoconus. Also will be evaluated the tomographic index as corneal curvature, thinnest
      point, corneal high order aberrations, posterior and anterior elevation, corneal
      densitometry, corneal volume. The idea is focused on that suspicious cornea that has the
      fellow eye with unequivocal keratoconus.
    


Study Type

Interventional


Primary Outcome

Evaluate the tomographic parameters of keratoconus, subclinical keratoconus in relation to sound corneas and identify the mutations present in the genes VSX1, SOD1 and TIMP3 in individuals affected by keratoconus.

Secondary Outcome

 Tomographic parameters

Condition

Keratoconus

Intervention

EVALUATION OF VSX1, SOD1, and TIMP3 genes

Study Arms / Comparison Groups

 keratoconus
Description:  Evaluation of Visual System Homeobox 1 (VSX1), Superoxide Dismutase (SOD1), Tissue Inhibitors of Metalloproteinases (TIMP3) genes. Keratoconus with fellow eye without topographic and tomographic keratoconous pattern.Evaluation of tomographic datas. Sometimes we picked up the sample of corneal epithelium, and peripheral blood sample from corneal cross linking surgeries, in that case of keratoconus progression.
Group A Keratoconus/ like sound cornea. Group C Keratoconus / Keratoconus
Group C Keratoconus / Keratoconus

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

Other

Estimated Enrollment

210

Start Date

August 1, 2015

Completion Date

December 31, 2016

Primary Completion Date

December 31, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Patients diagnosed with keratoconus in clinical examination, topography and tomography

          -  Patients with clinical examination, topography, and tomography aspect of sound cornea
             in one eye, and the fellow eye diagnosed with keratoconus by clinical examination,
             topography, and tomography.

        Patients diagnosed with keratoconus by clinical examination, topography, and tomography in
        both eyes (OU).

          -  Patients with some degree of ametropia that underwent to PRK and LASIK

        Exclusion Criteria:

          -  History of eye trauma, glaucoma, dysfunctional tear syndrome, rosacea, neurotrophic
             keratopathy, systemic or topical use of immunosuppressive drugs, previous ocular
             surgeries.
      

Gender

All

Ages

10 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Gildasio C Almeida Jr, MD, PhD, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT03071302

Organization ID

CAAE 44071315.7.0000.5415

Secondary IDs

2015/17226-7

Responsible Party

Principal Investigator

Study Sponsor

Sao Jose do Rio Preto Medical School

Collaborators

 Fundação de Amparo à Pesquisa do Estado de São Paulo

Study Sponsor

Gildasio C Almeida Jr, MD, PhD, Principal Investigator, FAMERP, Visum Eye Center


Verification Date

February 2017