LighTopTech Corp. — Department of Health and Human Services SBIR Phase I: NEI

Description

The corneathe outermost window of our visual systemis vulnerable to various types of infections and diseasesCorneal disease is one of the leading causes of visual deficiency and blindnessand is considered the second major cause of blindness in developing countriesThere are nearlymillion bilaterally corneal blind persons worldwideand an estimatedmillion people affected by unilateral corneal blindness globallyIn a conservative estimatecorneal diseases affect nearlypeople in the United Stateswith Fuchsdystrophy affectingof people aged overGiven the large prevalence of corneal disease and the near impossibility of performing biopsyhigh definition corneal imaging is needed to assist clinical diagnosisevaluate progression of diseasesand treatmentAdditionallythe cornea is the most commonly transplanted tissue worldwideInnearlycorneal transplants were performed incountries from tissue procured byeye bankswith the US having the highest rate of transplantationOver one half of the world s population does not have access to corneal transplantationresulting in a global shortage of corneal graft tissuewith onlyavailable out everycorneas neededEndothelial cells cannot regenerate in vivotherefore evaluation of their density is a very important measure of corneal healthThe shortage of available transplant tissue underscores the importance of reliableobjective methods to evaluate tissue quality at eye banks and ensure accurate selection of corneal grafts that are suitable for transplantationApproximatelyof the procured corneascorneas annuallyend up not being transplantedaccording to the Eye Bank Association of Americaof the corneas rejected are due to defects noticed during examinationAdditionallyaroundof transplants fail due to rejection of the corneathuseffective methods of monitoring reintegration of the tissue into the host are neededGabor domain optical coherence microscopyGD OCMis a high resolutionnon invasive imaging technology that can visualize microscopic structures in vivo inDPreliminary data suggest that GD OCM has the following key advantages over existing corneal imaging techniqueswhich include specular and confocal microscopyx increase in field of viewthis will lead to more accurate qualification of the corneal tissuesince a larger area can be assessedsimultaneous measure of corneal thicknessquantification of endothelial cell densityas well as identification of morphological variations due to corneal diseasethis will lead to full corneal evaluation in one instrumentD imaging capability at the cellular level of the mosaic of translucent corneal cellsthis will enable a detailed understanding the volumetric progression of the diseasesWe envision that in the future the GD OCM instrument enabled by this Phase I SBIR proposal will provide the early foundation for an image guidance method to assist clinicians in the assessment and treatment of corneal diseases and other diseases affecting the anterior segment of the eyeincluding diabetes and glaucoma