MacDx: Macula Diagnosis / Macular Dark Adaptation Test
FDA listing #D454868, Product Code OUM, Class I, Exempt Ophthalmic Device
Device: Adaptometer (biophotometer), software-based data acquistion and stimulus generator
FDA Registration #3004571972
U.S. Patent 11,026,573
Measures current macular function. The unique endpoint compares cone to rod function. Studies have shown that prolonged dark adaptation occurs in wet and dry macular degeneration, macular edema, diabetic maculopathy and other pathologies.
The test is performed on an Graphic Display Device. The technology is patented and the use of the testing program entails a licensing fee.
MacDx is sold as a turnkey graphic display devise containing the MacDx program for clinical trials. Free updates are included for the length of the lease.
Pilot Study, not peer reviewed