CTRI Number	CTRI/2019/07/020024 [Registered on: 04/07/2019] Trial Registered Prospectively
Last Modified On:	18/10/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Medical Device Surgical/Anesthesia
Study Design	Single Arm Study
Public Title of Study	Trail with Corneal Implant
Scientific Title of Study Modification(s)	Prospective Investigator Initiated Study to Evaluate the Biocompatibility and Indicative effectiveness of EndoArt in Subjects Having Corneal Edema with No Visual Potential
Secondary IDs if Any Modification(s)	Secondary ID  Registry  CLI-E001 Version 2 Dated September 1, 2017  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Prashant Garg  Address  Hyderabad Eye Research Foundation LV Prasad Eye Institute Kallam Anji Reddy Campus Banjara Hills LV Prasad Eye Institute Kallam Anji Reddy Campus Banjara Hills Hyderabad Hyderabad TELANGANA 500034 India  Phone  04030612555   Fax  040-23548271   Email  prashant@lvpei.org
Details Contact Person Scientific Query Modification(s)	Name  Dr Prashant Garg  Address  Hyderabad Eye Research Foundation LV Prasad Eye Institute Kallam Anji Reddy Campus Banjara Hills LV Prasad Eye Institute Kallam Anji Reddy Campus Banjara Hills Hyderabad TELANGANA 500034 India  Phone  04030612555   Fax  040-23548271   Email  prashant@lvpei.org
Details Contact Person Public Query Modification(s)	Name  Dr Prashant Garg  Address  Hyderabad Eye Research Foundation LV Prasad Eye Institute Kallam Anji Reddy Campus Banjara Hills LV Prasad Eye Institute Kallam Anji Reddy Campus Banjara Hills Hyderabad TELANGANA 500034 India  Phone  04030612555   Fax  040-23548271   Email  prashant@lvpei.org
Source of Monetary or Material Support Modification(s)	Eye Yon Medical Ltd 5 Golda Meir St. Ness Ziona 7403649, Israel
Primary Sponsor	Name  Eye Yon Medical Ltd  Address  5 Golda Meir St Ness Ziona 7403649, Israel  Type of Sponsor  Other [Medical Device Company]
Details of Secondary Sponsor	Name  Address  Hyderabad Eye Research Foundation  LV Prasad Eye Institute Kallam Anji Reddy Campus Banjara Hills Hyderabad 500034
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Prashant Garg  L V Prasad Eye Institute  LV Prasad Eye Institute Kallam Anji Reddy Campus Banjara Hills Hyderabad Hyderabad   04030612555 040-23548271 prashant@lvpei.org
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  L V Prasad Eye Institute Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Central corneal opacity  Patients  Corneal Edema with No Visual Potential
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  EndoArt   Artificial Endothelial Layer made of hydrophilic polymer Ci26  Comparator Agent  There is no comparator it is a single arm study  There is no comparator agent it is a single arm study
Inclusion Criteria Modification(s)	Age From  50.00 Year(s) Age To  85.00 Year(s) Gender  Both  Details  1. Male Female Subject is over 50 years old 2. No Visual Potential 3. Clinical Corneal Edema 4. Corneal thickness >650 μm 5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed. 6. Pseudophakic subject (anterior or posterior) with stable IOL.
ExclusionCriteria	Details  1. History of ocular Herpes keratitis 2. Subject with severely scarred cornea (unfit for regular endothelial keratoplasty) 3. Irregular posterior cornea (e.g. post PKP) 4. Active infection of the cornea 5. Band keratopathy and/or limbal stem cell deficiency. 6. Moderate to severe dry eye 7. Subject with phthisis or phthisis suspect 8. Very low ocular pressure ≤6 mmHg or higher than 25 mmHg. 9. Aphakia or subluxated lens or pseudophacodonesis 10. Subject with glaucoma shunt (e.g. Ahmend valve) 11. Subject with large iris defect which can compromise intraoperative AC stability. 12. Subjects after corneal refractive surgery. 13. Subject with neurotrophic corneal history 14. Subject with history of persistent corneal erosion difficulties with epithelial growth (re-epithelization) 15. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days.
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome	Outcome  TimePoints  The frequency and severity of all treatment-related adverse events, during and after implantation of the EndoArt™ and throughout the 6-month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infection  Day 1, 7,14 Week 4, 6, 8,10,12 Month 4, 5,6, 8,10,12
Secondary Outcome	Outcome  TimePoints  Corneal Clarity  baseline, week 4, 6, 8, 12 Month 6 ,12  Corneal Thickness   baseline, week 4, 8, 12 Month 6 ,12  Pain Assessment by a Visual Analogue Scale (VAS)  baseline, week 4, 8, 12 Month 6 ,12
Target Sample Size	Total Sample Size="12" Sample Size from India="12"
Phase of Trial	Phase 1/ Phase 2
Date of First Enrollment (India) Modification(s)	31/10/2019
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details Modification(s)	None Yet
Brief Summary	The cornea is a clear, transparent, dome-shaped structure that covers the front portion of the eyes. An adult cornea is about 0.5 millimeters thick. It comprises five major layers, namely, the epithelium, Bowman’s membrane, stroma, Descemet’s membrane, and endothelium. The cornea is kept transparent for maximum vision clarity by the pumping of water from the endothelium layer. When endothelial cells are injured, fluid begins to accumulate within the layers resulting in corneal edema which may lead to pain and blurred vision. Causes of corneal edema include: Iatrogenic post-operative, Fuchs’ dystrophy, infection, glaucoma and trauma. A primary symptom of corneal edema is blurred vision. The individual with corneal edema may also see halos or rainbows around streetlights, headlights and other bright lights at night. As corneal edema progresses, symptoms may include blisters that form on the surface of the eye. These can rupture and become painful, and also cause sensitivity to light. Corneal Edema is usually treated by applying Hyperosmotic agents such as hypertonic saline. When it is not initially effective, then a bandage contact lens is often used in conjunction with Hypertonic Saline, which may achieve limited improved vision and pain relief. Patients suffering from advanced chronic corneal edema are candidates for cornea transplant surgery. EyeYon Medical has developed the EndoArt™ (Artificial Endothelial Layer) implant which is a permanent implant. The EndoArt™ device is indicated for use as an endothelial keratoprosthesis device, and is designed specifically for replacement of the endothelial cell layer of the cornea that has become dysfunctional. With the development of endothelial keratoplasty techniques, surgeons are now able to remove only the diseased endothelial layer of the cornea and replace the layer with donor tissue, leaving the healthy areas of the cornea intact. The most common types of endothelial keratoplasty procedures, are Descemet’s Stripping Endothelial Keratoplasty (DSEK) and Descemet’s Membrane Endothelial Keratoplasty (DMEK). The EndoArt™ device is attached to the posterior corneal surface with acrylic material thereby impeding transfer of aqueous humor into the cornea and decreasing chronic corneal edema. The device may serve as an alternative to posterior lamellar keratoplasty (PLK) in providing alleviation of corneal edema and improving corneal clarity. As is done in PLK, a portion of the posterior cornea may be removed prior to insertion of the implant to the tissue as in DSEK or DMEK. EndoArt™ can be implanted using a suture less technique with or without striping the recipient endothelium. Development of the EndoArt™: the rational for blocking the posterior surface of the cornea came from clinical observation and sporadic literature data that corneas of eyes with silicon oil in the anterior chamber are usually transparent, despite very low endothelial count. Later on in the development it was discovered that in 1967 Dolman C. conducted a clinical trial on 22 patients suffering from chronic corneal edema. In this trial the endothelium was replaced with alloplastic material (silicon layer) and attached with sutures with relatively success. EndoArt™ implant is an alternative to human cornea endothelium represents a major advancement in keratoplasty, reducing the worldwide need for donor tissue from eye banks. Use of the EndoArt™ in place of donor corneal tissue simplifies the surgical procedure, since the implant is much more resilient then donor tissue during surgical manipulation. EndoArt™ also avoids the possibility of primary donor failure due to damage to donor tissue during harvesting, storage, insertion or unfolding. Importantly, transmission of infectious disease from donor to recipient is impossible with a keratoprosthesis. In India iatrogenic endothelial injury during surgical procedures is the most important cause of corneal edema. Several of these patients have other co-morbidities – secondary glaucoma, cystoid macular edema, disorganized anterior segment and corneal scars. Due to non-availability of quality donor corneal tissues secondary to poor eye banking state many patients are not able to get timely management of this painful condition. Further, recurrent epithelial break down predisposes these patients to corneal infections. Therefore, there is a need for an alternative treatment that can keep cornea dehydrated, prevent epithelial bullae formation and breakdown thereby providing symptomatic relief to patients, improving vision and prevent sequels and complications of chronic corneal edema. The present study is an Investigator Initiated Study and in this study, the EndoArt™ will be assessed in subjects suffering from corneal edema secondary to endothelial dysfunction, by using this clinical investigation plan.