PURPOSE: To report short-term results of pulsed ciliary muscle electrostimulation to improve near vision, likely through restoring accommodation in patients with emmetropic presbyopia. METHODS: In a prospective non-randomized trial, 27 patients from 40 to 51 years old were treated and 13 age- and refraction-matched individuals served as untreated controls. All patients had emmetropia and needed near sphere add between +0.75 and +1.50 diopters. The protocol included four sessions (one every 2 weeks within a 2-month period) of bilateral pulsed (2 sec on; 6 sec off) micro-electrostimulation with 26 mA for 8 minutes, using a commercially available medical device. The uncorrected distance visual acuity (UDVA) (logMAR) for each eye, uncorrected near (40 cm) visual acuity in each eye (UNVA) and with both eyes (UNVA OU) (logMAR), and reading speed (number of words read per minute at 40 cm) were measured preoperatively and 2 weeks after each session. Overall satisfaction (0 to 4 scale) was assessed 2 weeks after the last session. RESULTS:UDVA did not change and no adverse events were noted in either group. Bilateral and monocular UNVA and reading speed were stable in the control group, whereas they continuously improved in the treated group (Friedman, P < .00001). Post-hoc significant differences were found for monocular and binocular UNVA after the second treatment and after the first treatment considering words read per minute (P < .001). One patient (3.7%) was not satisfied and 18 patients (66.7%) were very satisfied (score of 4). Average satisfaction score was 3 (satisfied). CONCLUSIONS: Ciliary muscle contraction to restore accommodation was safe and improved the short-term accommodative ability of patients with early emmetropic presbyopia. [J Refract Surg. 2017;33(9):578-583.]. Copyright 2017, SLACK Incorporated.
RCT Entities:
PURPOSE: To report short-term results of pulsed ciliary muscle electrostimulation to improve near vision, likely through restoring accommodation in patients with emmetropic presbyopia. METHODS: In a prospective non-randomized trial, 27 patients from 40 to 51 years old were treated and 13 age- and refraction-matched individuals served as untreated controls. All patients had emmetropia and needed near sphere add between +0.75 and +1.50 diopters. The protocol included four sessions (one every 2 weeks within a 2-month period) of bilateral pulsed (2 sec on; 6 sec off) micro-electrostimulation with 26 mA for 8 minutes, using a commercially available medical device. The uncorrected distance visual acuity (UDVA) (logMAR) for each eye, uncorrected near (40 cm) visual acuity in each eye (UNVA) and with both eyes (UNVA OU) (logMAR), and reading speed (number of words read per minute at 40 cm) were measured preoperatively and 2 weeks after each session. Overall satisfaction (0 to 4 scale) was assessed 2 weeks after the last session. RESULTS: UDVA did not change and no adverse events were noted in either group. Bilateral and monocular UNVA and reading speed were stable in the control group, whereas they continuously improved in the treated group (Friedman, P < .00001). Post-hoc significant differences were found for monocular and binocular UNVA after the second treatment and after the first treatment considering words read per minute (P < .001). One patient (3.7%) was not satisfied and 18 patients (66.7%) were very satisfied (score of 4). Average satisfaction score was 3 (satisfied). CONCLUSIONS: Ciliary muscle contraction to restore accommodation was safe and improved the short-term accommodative ability of patients with early emmetropic presbyopia. [J Refract Surg. 2017;33(9):578-583.]. Copyright 2017, SLACK Incorporated.