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Clinical Development

Clinical Development: Known for our Process and Product Innovation
  • Preloaded DSAEK in the EndoGlide – 2012
  • No-touch DMEK hydro-dissection technique – 2012
  • Nan-Cut DSAEK grafts 40-70 microns – 2014
  • Preloaded DMEK Jones Tube – 2015
  • Preloaded DMEK in a LEITR 2.0 – 2018
  • Preloaded DMEK in EndoGlide – 2019
  • Preloaded DSAEK in LEITR 3.0 – 2020
  • OptiGraft – Sterile Ophthalmic Allografts – 2020

First Eye Bank to Distribute Preloaded Tissue

In 2012, LEITR’s clinical development team introduced the first preloaded corneal graft. Preloaded DSAEK grafts in an EndoGlide were developed through the collaboration and support of many ophthalmologists, specifically Dr. Kathryn Colby. Today LEITR offers more options to choose from for both DSAEK and DMEK grafts. 

Preloaded tissue reduces the surgical time of my cases, and I don’t have the stress of having to trephine and load my own tissue.- Kathryn A. Colby, M.D.

Blister Method

No-touch DMEK/PDEK graft separatation using hydrodissection technique

Optisol GS is used to create the initial separation of Descemet’s Membrane (DM) or Pre-Descemet’s Membrane. Trypan Blue is then introduced to complete the separation. During the process the graft is supported by fluid and the stain is isolated to the DM while the endothelium is protected.

Advantages over SCUBA

  • Tissue is not pulled or touched by forceps (no-touch)
  • Graft is supported throughout preparation (hydrodissection) 
  • Selective stromal staining limits exposure to Trypan Blue
  • Specular image post-prep of endothelium provided

Having peeled close to a thousand DMEK donors with the SCUBA technique has given me a unique perspective on the tremendous advantages of the LEITR hydrodissection technique (Blister Method). I only do the LEITR Blister Method. It’s a game changer!-Mark S. Gorovoy, MD

Abstracts: 
ASCRS 2018 Abstract-PDEK Blister technique
Cornea symposium 2016 -Abstract-DMEK Blister technique

Nan-Cut DSAEK grafts: 40-70 microns

High Pressurized Anterior Chamber (HPAC) Technique

Studies comparing tissue processing techniques for DSAEK show no statistical impact in endothelial cell loss between the HPAC and IV tubing method. However, the HPAC method provides several noteworthy benefits when utilized. The significant decrease in endothelial cell recovery time demonstrates less stress to endothelium, confirming this technique to be safe and less traumatic to endothelium. With repeatable control and accuracy thinner grafts (40-70 microns) are produced with less chance of perforations.

Abstracts:
ASCRS 2019 – High Pressurized Anterior Chamber (HPAC) technique

TransplantREADY LEITR DMEK 2.0

DMEK 2.0 was developed so one incision could be used for both cataract surgery and a corneal transplant.

 

TransplantREADY LEITR DSAEK 3.0

Designed specifically for preloaded Nano-Cut DSAEK grafts, LEITR DSAEK 3.0 promotes smaller incision sizes and no-touch delivery using fluid injection. As part of our medical advisory team and the lead surgeon in the development of this delivery system, Dr. Steven Kane worked with us for two years to perfect the design and technique before introducing it to other surgeons.

This injector system is a revolutionary way of doing DSAEK cornea surgery, with smaller wounds and a brand new “no-touch” technique. The system delivers the cornea transplant tissue into the eye without disturbing or damaging the graft.-Dr. Karen

Preparation
DSAEK grafts are prepared using high pressurized anterior chamber (HPAC) method yielding surgeons’ preferred graft thickness (precut). The graft is trephined to desired diameter (prepunched); orientation markings are added (premarked). Then the graft is tri-folded, loaded into the LEITR DSAEK 3.0 (preloaded), and placed in a vial of Optisol GS.

Validation Studies
Prepared DSAEK grafts, preloaded in new LEITR DSAEK 3.0, demonstrate minimal endothelial damage and allow for smaller incision size. A series of validation studies were conducted on each process used to prepare, load, store, transport and evaluate tissue distributed in LEITR DSAEK 3.0. In addition to validating endothelial cell viability, studies confirmed graft position and determined which graft sizes and thicknesses are supported.

Summary of results

  1. Endothelial cell loss: less than 5%
  2. Graft position maintained
  3. Graft thickness range: 40-70μ
  4. Graft diameters: 7.5, 7.75, and 8.0mm

Evaluation

Baseline measurements for cell damage were established on donor corneas with healthy endothelial cells post-preparation (0.2%). Grafts were tri-folded, loaded in LEITR DSAEK 3.0 with Optisol-GS, stored for 24 hours and then measured demonstrating only 2.8% cell damage.

Endothelial cell viability results

Storage & Transport

  • OCT images show the preloaded graft positioned in LEITR DSAEK 3.0 is rounded and maintains its shape without collapsing
  • Preloaded graft is stored in Optisol-GS and easily removed from the vial
  • Area of tissue overlap faces downward when bevel is up on insertion end
  • Graft orientation is visible inside LEITR DSAEK 3.0
OptiGraft: Sterile Ophthalmic Allografts

OptiGraft aligns well with our mission of setting new standards that transform and improve the lives of patients.

OptiGraft expands the applications and usable functionality of donated tissue, further honoring our commitment to our tissue donors and their families- Art Kurz, Chief Clinical and Marketing Officer

Sterilizing corneal and scleral tissue using irradiation allows us to provide sight restoration to even more patients. A cornea has the potential to help one patient in need of a sight restoring corneal transplant. Through the development of OptiGraft, we are able to process a cornea that is not suitable or unable to be placed for transplant within 14 days, and provide the gift of sight to as many as four people. We are able to provide benefit to as many as 16 people with sclera tissue from one donor. In addition, offering OptiGraft has expanded our reach to include glaucoma surgeons and their patients worldwide. 

Resources
OptiGraft Spec Sheet
OptiGraft_White Paper – Sterile Corneal Graft
OptiGraft_White Paper – Sterile Glaucoma Patch Graft

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