Gamma-Irradiated Corneal Inlay for Keratoconus

Learn more about:
Related Access Program
Related Clinical Trial
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

Gamma-Irradiated Corneal Inlay for Keratoconus

Official Title

Use of Gamma-Irradiated Preserved Corneal Tissue to Treat Keratoconus

Brief Summary

      Study objective is to evaluate the outcomes of placing gamma-irradiated corneal tissue
      (VisionGraft, CorneaGen, USA) within the cornea of patients with keratoconus, a procedure
      called Corneal Tissue Addition for Keratoconus (CTAK).
    

Detailed Description

      Using E gamma irradiated sterilized preserved corneal tissue, shaped corneal tissue inlays
      are placed in a keratoconic cornea. Preserved corneal tissue is currently available
      commercially from CorneaGen (VisionGraft,1200 6th Ave., STe.300, Seattle, WA 98101). Such
      tissue is currently used in a number of eye surgical procedures. It is considered suitable
      for corneal surgical procedures that do not require viable corneal endothelium, as is the
      case for a tissue enhancement procedure in keratoconus. The goal of the current protocol to
      evaluate the outcomes of placing gamma-irradiated preserved tissue within the keratoconic
      cornea in order to enhance corneal thickness, stability, and optical conformation.
    


Study Type

Interventional


Primary Outcome

Gamma-Irradiated Preserved Corneal Tissue Inlay

Secondary Outcome

 Gamma Irradiated Preserved Corneal Tissue Inlay

Condition

Keratoconus

Intervention

Gamma-irradiated corneal tissue inlay

Study Arms / Comparison Groups

 Corneal tissue inlay
Description:  The treated cornea will be implanted with a thin disc of gamma-irradiated preserved corneal tissue

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

Procedure

Estimated Enrollment

10

Start Date

February 1, 2021

Completion Date

June 1, 2022

Primary Completion Date

February 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  At least 18 years of age, male or female, of any race

          -  Provide written consent and sign a HIPAA form

          -  Willingness and ability to follow all instructions and comply with schedule for
             follow-up visits

          -  For females: must not be pregnant

          -  Having topographic evidence of keratoconus which is graded as moderate or severe
             keratoconus defined as the following:

               -  Moderate Keratoconus: Axial topography consistent with keratoconus, Maximum
                  keratometry on Pentacam greater than or equal to 51.01 D

               -  Severe Keratoconus: Axial topography consistent with keratoconus with marked
                  areas of steepening, Maximum keratometry on Pentacam greater than or equal to
                  56.01 D

          -  Presence of central or inferior steepening on the Pentacam map

          -  BSCVA less than or equal to 20/25

          -  Contact lens wearers only: remove contact lenses one week prior to the screening
             refraction

        Exclusion Criteria:

          -  Contraindications, sensitivity or known allergy to the use of the test article(s) or
             their components

          -  If female, be pregnant

          -  Eyes classified as either normal, atypical normal, keratoconus suspect or mild
             keratoconus on the severity grading scheme

          -  Previous ocular condition (other than refractive error) in the eye to be treated that
             may predispose the eye for future complications. For example:

             a) History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal
             melt, corneal dystrophy, etc.)

          -  A history of delayed epithelial healing in the eye to be treated

          -  Have used an investigational drug or device within 30 days of the study or be
             concurrently enrolled in another investigational drug or device study within 30 days
             of the study
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Peter S Hersh, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04895514

Organization ID

GAMMA TISSUE INLAY


Responsible Party

Sponsor

Study Sponsor

Cornea and Laser Eye Institute


Study Sponsor

Peter S Hersh, MD, Principal Investigator, Cornea and Laser Eye Institute


Verification Date

May 2021