Evaluation of eyes implanted with corneal inlays for correction of presbyopia
- Conditions
- PresbyopiaH52.4
- Registration Number
- RBR-2pxh57
- Lead Sponsor
- niversidade Federal de Sao Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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