: Therapeutic Restoration Of Dynamic Range Of Focus Utilizing Laser Scleral Microporation

To evaluate Dynamic Range of Focus (DRoF) in presbyopes following binocular Laser Scleral Microporation (LSM).

Subjects were enrolled in a multicenter pilot study to evaluate the safety and efficacy of the Laser Scleral Microporation (LSM) to restore visual accommodation and  function 

96 eyes of 48 patients were treated in the study using a 2.94um  Er:YAG laser to create a matrix of 255um microporations in the 4 oblique quadrants of each eye in 5 critical zones of the sclera.  Subjects greater than 47yrs of age demonstrating at least a +1.5D add with 20/50 or worse DCNVA included in the study. The aim of LSM is to uncrosslink the scleral microfibrils to decrease biomechanical stiffness. The goal is improving  biomechanical efficiency of the ciliary muscles to rejuvenate the accommodative mechanism and  restore Dynamic Range of focus (DRoF). Early Diabetic Retinopathy Study (EDTRS) logMAR charts at distance, 60cm, and 40cm.  Goldman tonometry was used to measure intraocular pressure (IOP) before and after the procedure.

LSM provided improvement in both uncorrected and distance corrected intermediate and near visual acuity (UIVA/UNVA and DCIVA/DCNVA) with no significant changes to distance vision. Early results demonstrated that patients enjoy significant improvement in their binocular UNVA/UIVA and DCNVA/DCIVA at 3 and 6 months postoperatively compared to preoperative visual acuity. LSM also produced a reduction in intraocular pressure as measured with Goldmann tonometry. 

Early clinical trial results suggest LSM to be a safe and effective procedure for restoring dynamic range of focus in presbyopes. Early results suggest that LSM can improve intermediate and near visual acuity without touching the visual axis or comprising distance vision. A reduction in IOP was reported.  Data collection is ongoing.