SBIR-STTR Award

Small Incision Artificial Cornea
Award last edited on: 1/17/18

Sponsored Program
SBIR
Awarding Agency
NIH : NEI
Total Award Amount
$1,744,224
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Yichieh Shiuey

Company Information

Keramed Inc

4122 East Chapman Avenue 2nd Floor Suite 26
Orange, CA 92869
   (973) 276-1414
   info@keramed.com
   www.keramed.com
Location: Single
Congr. District: 45
County: Orange

Phase I

Contract Number: 1R44EY021664-01
Start Date: 6/1/11    Completed: 11/30/11
Phase I year
2011
Phase I Amount
$284,740
The objective of this grant proposal is to perform a clinical study which will allow the first foldable and injectable artificial cornea, the KeraKlear, to be used in the United States market for treatment of corneal blindness. This device may be implanted through an incision size that is approximately 1/10th the size of the incision that is required for the most popular artificial cornea available in the U.S. The smaller incision size is expected to allow a much quicker surgery for patients and a more accelerated recovery as compared to the currently available artificial corneas. In addition, the KeraKlear artificial cornea may be implanted in many patients with cornea blindness without penetration into the anterior chamber. This avoids two of the most serious complications of artificial cornea implantation including internal infection of the eye (endophthalmitis) and severe bleeding (expulsive hemorrhage). The use of the KeraKlear artificial cornea also avoids the common complications of corneal transplantation including high astigmatism, corneal graft failure and corneal graft rejection. Finally, the KeraKlear would enable the treatment of cornea blindness in a much larger number of patients. Currently, corneal transplantation is limited to about 100,000 per year worldwide because of the lack of suitable donor corneas. This represents only 1% of the 10 million people worldwide who have cornea blindness in both eyes. By making the KeraKlear artificial cornea available a significantly larger percentage of the cornea blind patients around the world could be treated.

Public Health Relevance:
A new type of foldable and injectable artificial cornea has been developed for placement through a small incision (3 mm). In this project, we will perform clinical studies to determine the safety and efficacy of this new device. Successful completion of the study will lead to the availability of this less invasive artificial to cornea blind patients in the U.S.

Thesaurus Terms:
Active Follow-Up;Adverse Experience;Adverse Event;Anterior;Anterior Chamber;Anterior Chamber Of The Eye;Anterior Chamber Of Eye Structure;Applications Grants;Astigmatism;Bleeding;Blindness;Clinical Research;Clinical Study;Cornea;Corneal Transplantation;Data;Devices;Effectiveness;Endophthalmitis;Eye;Eye Infections;Eyeball;Graft Rejection;Grafting, Corneal;Grant;Grant Proposals;Grants, Applications;Hemorrhage;Human;Human, General;Implant;Injectable;Keratomileusis, Laser In Situ;Keratoplasty;Lasik;Lamellar Keratoplasty;Laser In Situ Keratomileusis;Laser Intrastromal Keratomileuses;Laser Intrastromal Keratomileusis;Laser-Assisted Stromal In Situ Keratomileusis;Lead;Macular Degeneration;Macular Degenerative Disease;Man (Taxonomy);Man, Modern;Marketing;Measures;Methods And Techniques;Methods, Other;National Eye Institute;Ocular Infections;Operation;Operative Procedures;Operative Surgical Procedures;Ophthalmia;Otomy;Outcome;Outcome Study;Patients;Pb Element;Penetrating Keratoplasty;Penetration;Phase;Physical Health Services / Rehabilitation;Pilot Projects;Qol;Quality Of Life;Questionnaires;Recovery;Rehabilitation;Rehabilitation Therapy;Rehabilitation, Medical;Reporting;Safety;Sight;Staging;Surgical;Surgical Interventions;Surgical Procedure;Surgical Incisions;Techniques;Technology;Testing;Transplant Rejection;Transplantation Rejection;Transplantation, Cornea;United States;Vision;Visual;Visual Acuity;Anterior Chamber;Base;Blind;Blood Loss;Corneal;Corneal Keratoplasty;Corneal Surgery;Corneal Transplant;Follow-Up;Graft Failure;Heavy Metal Pb;Heavy Metal Lead;Implantation;Incision;Phase 2 Study;Pilot Study;Rehabilitative;Success;Surgery

Phase II

Contract Number: 4R44EY021664-02
Start Date: 6/1/11    Completed: 9/29/15
Phase II year
2013
(last award dollars: 2017)
Phase II Amount
$1,459,484

The objective of this grant proposal is to perform a clinical study which will allow the first foldable and injectable artificial cornea, the KeraKlear, to be used in the United States market for treatment of corneal blindness. This device may be implanted through an incision size that is approximately 1/10th the size of the incision that is required for the most popular artificial cornea available in the U.S. The smaller incision size is expected to allow a much quicker surgery for patients and a more accelerated recovery as compared to the currently available artificial corneas. In addition, the KeraKlear artificial cornea may be implanted in many patients with cornea blindness without penetration into the anterior chamber. This avoids two of the most serious complications of artificial cornea implantation including internal infection of the eye (endophthalmitis) and severe bleeding (expulsive hemorrhage). The use of the KeraKlear artificial cornea also avoids the common complications of corneal transplantation including high astigmatism, corneal graft failure and corneal graft rejection. Finally, the KeraKlear would enable the treatment of cornea blindness in a much larger number of patients. Currently, corneal transplantation is limited to about 100,000 per year worldwide because of the lack of suitable donor corneas. This represents only 1% of the 10 million people worldwide who have cornea blindness in both eyes. By making the KeraKlear artificial cornea available a significantly larger percentage of the cornea blind patients around the world could be treated.

Public Health Relevance Statement:
A new type of foldable and injectable artificial cornea has been developed for placement through a small incision (3 mm). In this project, we will perform clinical studies to determine the safety and efficacy of this new device. Successful completion of the study will lead to the availability of this less invasive artificial to cornea blind patients in the U.S.

NIH Spending Category:
Clinical Research; Eye Disease and Disorders of Vision; Transplantation

Project Terms:
Adverse event; Anterior; anterior chamber; Applications Grants; Astigmatism; base; blind; Blindness; Clinical Research; Cornea; corneal surgery; Data; Devices; Effectiveness; Endophthalmitis; Eye; Eye Infections; follow-up; graft failure; Graft Rejection; Grant; Hemorrhage; Human; Implant; implantation; Injectable; Keratoplasty; Lamellar Keratoplasty; Laser In Situ Keratomileusis; Lead; Macular degeneration; Marketing; Measures; National Eye Institute; Operative Surgical Procedures; Outcome; Outcome Study; Patients; Penetrating Keratoplasty; Penetration; Phase; phase 2 study; Pilot Projects; Quality of life; Questionnaires; Recovery; Rehabilitation therapy; Reporting; Safety; Staging; success; Surgical incisions; Techniques; Technology; Testing; United States; Vision; Visual; Visual Acuity