In diabetic maculopathy, fluid rich in fat and cholesterol leaks out of damaged vessels. If the fluid accumulates near the center of the retina (the macula) as indicated by the black pointer there will be distortion of central vision. If too much fluid and cholesterol accumulates in the macula, it can cause permanent loss of central vision. CSME (clinically significant macular edema) is the term given to describe water logging of the macular area.

In diabetic retinopathy, the vessels become more permeable. Water, blood cells, proteins, fats, and other large molecules may leak out into the surrounding retinal tissue. Accumulation of this fluid in the central region of the retina (the macula) is called macular edema or diabetic maculopathy. Diabetic Maculopathy is the most common cause of decreased vision in patients with background or nonproliferative diabetic retinopathy. It is visible on examination as a thickening and slight graying of the retina, and is often associated with exudates (yellow clumps or spots within the retina). Exudates are the result of fats and proteins leaking out of the permeable vessels along with water. The water can be quickly reabsorbed into the vessels or into the tissue under the retina, but the fatty material is absorbed only very slowly. These fatty exudates are left behind like a "bathtub ring", often in a ring-like shape surrounding the leakage site.

Diabetic maculopathy is often described as being either focal or diffuse, and treatment of the edema is specific to the type. Focal macular edema is swelling due to leakage from a few specific spots in the retina, usually leaking micro aneurysms or dilated retinal vessels. Treatment of focal macular edema is done by coagulating the individual micro aneurysms or leaking vessels in order to stop the leakage. A 50-100 micron spot of laser is applied to the micro aneurysm with sufficient power to produce whitening or coagulation. Diffuse macular edema is caused by leakage from multiple retinal vessels as well as from the pigmented cells under the retina. It would be impossible to treat all areas of leakage in a case of diffuse edema. Instead, a grid pattern of laser spots are placed around the center of the macula. The mechanism by which grid laser treatment works is unknown, but may have to do with destroying abnormal pigmented cells and allowing more normal cells to replace them.

Resolution/Product The very inexpensive, MDD-1TM Macular Defective Detection Device‟ developed and produced by Health Research Sciences, Inc. (HRS) enables Optometrist, Ophthalmologist, Endocrinologist, Primary Care Doctors, and even patients themselves in the home environment to easily and efficiently screen for the early detection of Age Related Macular Degeneration and Diabetic Maculopathy as well as other types of central retinal diseases in the human eye. The MDD-1 also permits monitoring of central retinal health over time, and can warn of deterioration in function at an early stage.

The MDD-1 is a Patented, unique design that solves the problem of inconsistent testing and screening as currently performed by providing reproducible measurements of macular function (light flash recovery, dark adaptation) that are recorded and made available in a concise reporting format for health professional interpretation. The instrument also warns end users that a doctor‟s visit is warranted.

It is envisioned that the MDD-1 would be sold directly to these Physicians in enough quantity per office to facilitate the screening of patients that fit the target patient demographic in their normal busy weekly schedules.

HRS will develop the educational and marketing material required to supply the physicians with what is needed to inform and educate their patient populations about the presence of the MDD-1 in their office and the need and ability to have screening and monitoring performed on patients that are in the risk demographic. The educational material developed for this purpose by HRS will contain the statistical information about the screened and monitored diseases and the need to be screened.

It is estimated that the total reduction in cost of care is significant as many large Eye Health Organizations in the US have already evaluated the MDD-1 and concluded and reported to HRS that “early detection and standardization of the test parameters and baselines is what is needed to screen these diseases at an early stage which would allow the initiation or augmentation of inexpensive initial therapies (including the use of Nutriceuticles), or more involved treatments (laser, anti-VEGF injections) as may be indicated for more advanced disease.

Conclusion The MDD-1 Macular Defective Detection Device is the only testing and screening device of its type in the world and the same “large Eye Health Organizations in the US” that have initially reviewed the MDD-1 have stated that they believe that “every Doctor they know needs to have one to raise the standard of care for screening for these diseases and monitoring the success of applied therapies and corrective surgery”.