Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes.
To report 1-year safety and efficacy clinical outcomes of a shape-changing corneal inlay for the treatment of presbyopia.
Prospective, nonrandomized, multicenter United States Food and Drug Administration Investigational Device Exemption clinical trial (clinicaltrials.gov identifier, NCT01373580).
Nondominant eyes (N = 373) of emmetropic presbyopic subjects were implanted at 11 sites with the Raindrop Near Vision Inlay (ReVision Optics, Lake Forest, CA); 340 eyes underwent the 1-year follow-up visit.
The corneal inlay was implanted under a corneal flap at the center of the light-constricted pupil created with a femtosecond laser.
For subjects completing the 1-year follow-up, monocular and binocular uncorrected and corrected visual acuity, refractive stability, contrast sensitivity (CS; photopic and mesopic), symptom and satisfaction questionnaire results, and adverse events.
At 1 year in the treated eye, on average, uncorrected near visual acuity (UNVA) improved by 5.1 lines, uncorrected intermediate visual acuity (UIVA) improved by 2.5 lines, and uncorrected distance visual acuity (UDVA) decreased by 1.2 lines. From 3 months through 1 year, 93% of subjects achieved UNVA of 20/25 or better, 97% achieve UIVA of 20/32 or better, and 95% achieved UDVA of 20/40 or better. Binocularly, the mean UDVA exceeded 20/20 from 3 months through 1 year. Contrast sensitivity loss occurred only at the highest spatial frequencies, with no loss binocularly. Absent or mild scores were reported in 96% of subjects for visual symptoms (glare, halos, double vision, and fluctuations in vision), in 99% for ocular symptoms (pain, light sensitivity, and discomfort), and in 95% for dryness. Adverse events were treatable and resolved. Eighteen inlays were replaced, usually soon after implantation because of decentration, but UNVA was little affected in this group thereafter. In the 11 cases requiring inlay explantations, 100% achieved a corrected distance visual acuity of 20/25 or better by 3 months after explant.
The Raindrop Near Vision Inlay provides significant improvement in near and intermediate visual performance, with no significant change in binocular distance vision or CS. Subject satisfaction is improved significantly with minimal ocular or visual symptoms.
Whitman J
，Dougherty PJ
，Parkhurst GD
，Olkowski J
，Slade SG
，Hovanesian J
，Chu R
，Dishler J
，Tran DB
，Lehmann R
，Carter H
，Steinert RF
，Koch DD
... -
《-》
Visual outcomes and safety of a refractive corneal inlay for presbyopia using femtosecond laser.
To evaluate the outcomes and safety of a refractive inlay (Flexivue Micro-Lens, Presbia Coöperatief U.A.) for the corneal compensation of presbyopia.
This prospective, interventional clinical study comprised 47 emmetropic presbyopes with a mean age of 52±4 years (range: 45 to 60 years). The inlay was inserted, centered on the line of sight, inside a corneal pocket created in the patient's nondominant eye, using a femtosecond laser. Follow-up was 12 months. Visual acuity, corneal topography, wavefront aberrometry, contrast sensitivity, structural corneal alterations, and questionnaires were evaluated.
Twelve months after surgery, uncorrected near visual acuity was 20/32 or better in 75% of operated eyes, whereas mean uncorrected distance visual acuity (UDVA) of operated eyes was statistically significantly decreased from 0.06±0.09 logMAR (20/20) (range: -0.08 to 0.26) preoperatively to 0.38±0.15 logMAR (20/50) (range: 0.12 to 0.8) (P<.001), and mean binocular UDVA was not significantly altered (P=.516). Seventeen patients lost one line of corrected distance visual acuity in the operated eye. No patient lost 2 lines in CDVA in the operated eye. Overall, higher order aberrations increased and contrast sensitivity decreased in the operated eye. No tissue alterations were found using corneal confocal microscopy. No intra- or postoperative complications occurred.
Twelve months after implantation, the Flexivue Micro-Lens intracorneal refractive inlay seems to be an effective method for the corneal compensation of presbyopia in emmetropic presbyopes aged between 45 and 60 years old.
Limnopoulou AN
，Bouzoukis DI
，Kymionis GD
，Panagopoulou SI
，Plainis S
，Pallikaris AI
，Feingold V
，Pallikaris IG
... -
《-》
One-year visual outcomes and patient satisfaction after surgical correction of presbyopia with an intracorneal inlay of a new design.
To evaluate the safety and efficacy of the third-generation Kamra corneal inlay (ACI 7000PDT) implanted monocularly in corneal pockets of emmetropic presbyopic patients to improve near and intermediate vision.
University Eye Clinic, Paracelsus Medical University, Salzburg, Austria.
Cohort study.
The corneal inlay was implanted in the nondominant eye over the line of sight by creating a corneal pocket with a femtosecond laser. The minimum postoperative follow-up was 12 months. Distance, intermediate, and near visual acuities were assessed over the follow-up. Other examinations included slitlamp evaluation, central keratometry, computerized corneal topography, endothelial cell count, and central corneal thickness. Patients completed satisfaction questionnaires preoperatively and 3, 6, and 12 months postoperatively.
The study evaluated 24 patients. After a mean follow-up of 12 months, 92% of patients read Jaeger (J) 3 or better with the surgical eye, the mean binocular uncorrected near visual acuity improved from J5 preoperatively to J2, and the mean binocular uncorrected intermediate visual acuity was 20/20 (67% ≥ 20/20). At 12 months, the mean uncorrected distance visual acuity was 20/20 in the surgical eye and 20/16 binocularly. Patients reported no change in distance vision, and their need for reading glasses decreased significantly (P<.001). No inlay was explanted and or recentered during the reported follow-up.
The new corneal inlay was a safe and effective treatment for presbyopia over a 1-year follow-up.
Dexl AK
，Seyeddain O
，Riha W
，Hohensinn M
，Rückl T
，Reischl V
，Grabner G
... -
《-》
Small-aperture corneal inlay for the correction of presbyopia: 3-year follow-up.
To report the 3-year postoperative safety and efficacy outcomes of the Acufocus corneal inlay.
University Eye Clinic, Paracelsus Medical University, Salzburg, Austria.
Prospective nonrandomized noncomparative cohort study.
The corneal inlay was implanted in the nondominant eye of naturally emmetropic presbyopic patients. Refraction, uncorrected near (UNVA), intermediate (UIVA), and distance (UDVA) visual acuities; corrected distance visual acuity (CDVA); contrast sensitivity; visual fields; subjective patient satisfaction and symptoms; and operative and postoperative adverse events and complications were evaluated.
The study enrolled 32 patients. The mean UNVA improved from Jaeger (J) 6 preoperatively to J1 at 3 years and the mean UIVA, from 20/40 to 20/25, respectively. At 3 years, 97% of eyes had a UNVA of J3 or better and 91% had a UIVA of 20/32 or better. The mean UDVA was 20/20, with all eyes achieving 20/32 or better. Nine eyes (28.3%) lost 1 line of CDVA, 1 eye (3.1%) lost more than 2 lines (3.8 lines), and 3 eyes (9.3%) gained 1 line. No inlay was explanted, and no inflammatory reactions were observed. At 3 years, 15.6% of patients reported severe night-vision problems and 6.3% (versus 87.5% preoperatively) reported being dependent on reading glasses.
These 3-year results support the safety and efficacy of the corneal inlay to correct presbyopia in naturally emmetropic presbyopic patients. However, despite a significant gain in UNVA and UIVA, 28.3% of patients lost 1 line of CDVA.
Seyeddain O
，Hohensinn M
，Riha W
，Nix G
，Rückl T
，Grabner G
，Dexl AK
... -
《-》
ResearchGate
(全网免费下载)
钛学术
(全网免费下载)
