First Author: V.Feingold USA
Co Author(s): I. Pallikaris M. Fantozzi
Purpose:
To prospectively assess self-reported patient outcomes after insertion of the Presbia Flexivue Microlens (a bifocal refractive corneal inlay) as a treatment of presbyopia in patients between 45 and 60 years of age.
Setting:
: Academic-based ophthalmic surgery practices in Greece (Vardinoyannion Eye Institute of Crete, University of Crete, Greece) and Italy (Ophthalmology Department, Misericordia e Dolce Hospital, Prato and University of Siena, Siena).
Methods:
Sixty-four (64) eyes of 64 emmetropic patients (n = 42 Greece and n = 22 Italy) were treated with a bifocal refractive corneal inlay. All inlays were inserted into corneal pockets created using a 150 kHz femtosecond laser (iFS 150, AMO, Santa Ana, CA, USA) at a depth of 280 to 300 µm. Average age was 52.3 (± 4.25) years. All patients underwent a number of ocular examinations to verify inclusion criteria of the evaluation were met, and all patients were required to participate in a short trial to determine tolerance to adaptive monovision (i.e., best spectacle corrected distance with near add in place) before surgery. Patients were asked about occupation and the most important postoperative near expectation as an outcome of the surgery. The majority of patients (n = 30 (48%)) were in business-related professions (e.g., public and private management, banking); the most important postoperative near expectation for the majority of patients was reading newspapers or books (n = 42 (68%)). The mean preoperative uncorrected near visual acuity was 0.70 (± 0.19) logMAR.
Results:
Sixty-two (62) patients (n = 41 Greece and n = 21 Italy) were followed through Month 12 postoperative; two patients were lost to follow-up. Postoperative patient satisfaction was assessed using a short patient questionnaire consisting of seven questions. At month 12, 97% (n = 37/60, 2 patients did not respond) of patients rated perception of uncorrected near vision in the operated eye as Excellent or Good, and 3% (n = 2) rated near vision as Fair; 0% of patients rated uncorrected near vision as Poor. Seventy-four percent (74%, n = 45/61, 1 patient did not respond) did not require spectacles after surgery and 26% (n = 15/61) reported use of spectacles less than 50% of the time; there were no reports of the need for spectacles more than 50% of the time or all of the time for near vision. At Month 12, the mean postoperative uncorrected near visual acuity was 0.11 (± 0.12) logMAR, which is approximately six lines of improvement versus the preoperative mean.
Conclusions:
Ninety-eight percent (98%) of patients reported that they were happy with their uncorrected near vision at Month 12 postoperative, and overall patient satisfaction with the postoperative outcomes remained high through the end of the study. In this evaluation, the Microlens provided the majority of patients with enhanced near vision without the need for spectacles.
Financial Disclosure:
... is employed by a for-profit company with an interest in the subject of the presentation
