Presbyopia
Conditions
Interventions
Intracorneal inlay to correction presbyopia in 31 patients..Follow up of one year. Patients were followed according to a clinical protocol including refraction, anterior segment imaging analysis (Ocul
Procedure/surgery
H52.4
C11.744.786
Sponsors
Universidade Federal de Sao Paulo
PresbiBio
Eligibility
Age
45 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age between 45 years and 60 years, both gender, uncorrect near visual acuity (UNVA) worse than J4, uncorrect distance visual acuity (UDVA) better than 20/40, corrected near visual acuity (CNVA) and correted disttanve visua acuity(CDVA) better than 20/20, spherical equivalent (SE) refraction for distance ranging between 0.25 diopter (D) and 1.00 D, up to 0,75 D of astigmatism, full-time reading glasses for near visual tasks required for a minimum of 1 year, clearly determined ocular dominance, central corneal thickness (CCT) greater than 500 micra, mesopic pupilary diameter more than 3mm and endothelial cell count 2000 cells/mm2 in the eye to be implanted
Exclusion criteria
Exclusion criteria: Anterior and posterior segment pathology, including cataracts in the eye to be implanted, previous intraocular or corneal surgery including cataract and LASIK surgery, chronic systemic or topical corticosteroids, or other immunosuppressive therapy that may affect wound healing, and any immuno-compromised subjects, systemic medications with significant ocular side effects and subjects who use telescopes or microscopes for professional reasons, or have high vision requirements or expectations like surgeons, architects, accountants, professional athletes or pilots.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this study, Presbia Flexivue Microlens™ provided patients with improved near vision in all 31 patients, in 1 year follow up.So ,the study came to the conclusion that we looked, as the improve the near vision in all the cases;The mean uncorret near visual acuity improved to Jaeger 1 in 90,32% of eyes treated with the inlay. All eyes improved four lines in all visits. The binocular uncorret distance visual acuity is 20/20 in all cases. Patients reported near vision to be good or excellent in 90,03%. There were 16,1% patients, whom lost more than 3 lines incorret distance visual acuity. No intraoperative or postoperative complications are reported | — |
Secondary
| Measure | Time frame |
|---|---|
| The near vision improved because of shift miopic and the increase of high order aberration, as spherical aberration in all patients.We expected that the near vision improve due the myopia caused by the presence of the lens.So,our results proved that we were corrected.;Evaluation of hig order aberration,also note an increase of Coma aberration and the Trefoil aberration.In the contrast analysis over the time, both mesophic and escothopic decrease after the surgery | — |
Countries
Brazil
Contacts
Public ContactSandra Beer
Universidade Federal de Sao Paulo
Outcome results
None listed