AcuFocus Corneal Inlay to Correct Presbyopia Using Femto-LASIK. One Year Results of a Prospective Cohort Study

Jalali, Shahrokh; Au, W. Aus der; Shaarawy, Tarek

doi:10.1055/s-0041-111804

Cited by 16 publications

(13 citation statements)

References 10 publications

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“…According to their guidelines, <5% of eyes should lose two or more lines of Mono CDVA at 12 months postoperatively, and in our results, 0.6% (3/479) fit this criterion 4. In our results, we found that none of our patients lost two or more Snellen lines of Mono CDVA, yet 17% (2/12) lost one line of sight at 6 months.…”

Section: Discussionsupporting

confidence: 65%

“…The small-aperture inlay (KAMRA; AcuFocus, Inc, Irving, TX, USA) has shown effective results in the treatment of presbyopia,4–7 and in April 2015, the US Food and Drug Administration (FDA) approved its use in the US. Using the pinhole technique, the inlay focuses light as it enters the eye to improve the depth of field and reading vision.…”

Section: Introductionmentioning

confidence: 99%

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Short-term visual result after simultaneous photorefractive keratectomy and small-aperture cornea inlay implantation

Moshirfar¹,

Wallace²,

Skanchy³

et al. 2016

OPTH

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PurposeTo report the short-term results of simultaneous photorefractive keratectomy (PRK) and small-aperture cornea inlay implantation (KAMRA) surgery in treating presbyopia.MethodsSimultaneous PRK and KAMRA inlay surgery was performed on 21 patients from July 2015 to March 2016. Follow-up exams were conducted at 1, 3, and 6 months postoperatively. Our patients were also divided preoperatively into three categories: myopic, hyperopic, and emmetropic. Over the 6-month period, the main outcome measures were uncorrected near visual acuity (UNVA), changes in best-corrected distance visual acuity, and mean spherical equivalent refraction.ResultsAt 6-month follow-up, 83% (10/12) of patients had a monocular UNVA of 20/40 or better, and 75% had a binocular UNVA of 20/40 (J5) or better. At 6 months, the overall mean refractive spherical equivalent (MRSE) was −0.60 D (±0.42 standard deviation [SD], range: −1.38 to −0.13) with a mean change of −0.43 D (±1.19 SD, range: −1.5 to 2.63) compared to preoperative data. Overall, 91% (10/11) of patients were within a ±0.5 D range of our target −0.75 D for KAMRA use. One-hundred percent (5/5) of the hyperopes, 50% (1/2) of emmetropes, and 100% (4/4) of myopes met the targeted range. At 6 months, the MRSE for the hyperopic subgroup (n=5) was 0.33 D (±0.20 SD), the MRSE for the emmetropic subgroup (n=2) was −1.19 D (±0.19 SD), and the MRSE for the myopic subgroup (n=4) was −0.66 D (±0.36 SD).ConclusionBased on preliminary results and a small sample size, it seems that simultaneous PRK and KAMRA is effective and predictable. There are multiple advantages in performing simultaneous PRK and KAMRA including a shorter recovery time and less steroid use than the two surgeries performed separately.

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Section: Discussionsupporting

confidence: 65%

Section: Introductionmentioning

confidence: 99%

Short-term visual result after simultaneous photorefractive keratectomy and small-aperture cornea inlay implantation

Moshirfar¹,

Wallace²,

Skanchy³

et al. 2016

OPTH

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“…based on the USA regulatory submission of the corneal inlay clinical trials to date (Moshirfar et al, 2017) suggests both inlay types are safe, but secondary surgical intervention was required in 12% of thin lens inlays within 3 years of implantation; a drop in corrected visual acuity of ≥2 acuity lines was more common in pinhole inlays (3.4% vs 1.0%). However, clinical studies suggest that when implanted monocularly in the non-dominant eye meniscus shaped inlays cause only minimal distance visual acuity compromise in the implanted eye and provide good near acuity, stereopsis and contrast sensitivity (Igras et al, 2016a, b;Jalali et al, 2016;Lin et al, 2016;Linn et al, 2017). They can be implanted safely with similar outcomes before or after traditional or femtosecond laser-assisted cataract surgery (Ibarz et al, 2017;Stojanovic et al, 2016) and with simultaneous photorefractive keratectomy (PRK) (Moshirfar et al, 2016b).…”

Section: Inlaysmentioning

confidence: 99%

Presbyopia: Effectiveness of correction strategies

Wolffsohn

Davies

2019

Progress in Retinal and Eye Research

231

178

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Presbyopia is a global problem affecting over a billion people worldwide. The prevalence of unmanaged presbyopia is as high as 50% of those over 50 years of age in developing world populations, due to a lack of awareness and accessibility to affordable treatment, and is even as high as 34% in developed countries. Definitions of presbyopia are inconsistent and varied, so we propose a redefinition that states "presbyopia occurs when the physiologically normal age-related reduction in the eye's focusing range reaches a point, when optimally corrected for distance vision, that the clarity of vision at near is insufficient to satisfy an individual's requirements". Strategies for correcting presbyopia include separate optical devices located in front of the visual system (reading glasses) or a change in the direction of gaze to view through optical zones of different optical powers (bifocal, trifocal or progressive addition spectacle lenses), monovision (with contact lenses, intraocular lenses, laser refractive surgery and corneal collagen shrinkage), simultaneous images (with contact lenses, intraocular lenses and corneal inlays), pinhole depth of focus expansion (with intraocular lenses, corneal inlays and pharmaceuticals), crystalline lens softening (with lasers or pharmaceuticals) or restored dynamics (with 'accommodating' intraocular lenses, scleral expansion techniques and ciliary muscle electrostimulation); these strategies may be applied differently to the two eyes to optimise the range of clear focus for an individual's task requirements and minimise adverse visual effects. However, none fully overcome presbyopia in all patients. While the restoration of natural accommodation or an equivalent remains elusive, guidance is given on presbyopic correction evaluation techniques.

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“…Corneal inlays for correction of presbyopia may be implanted under a flap or into a stromal pocket to increase the depth of field (Kamra inlay, AcuFocus), alter the refractive index of the central cornea (Presbia Flexivue Microlens, Presbia Cooperatief), or reshape the corneal surface (Raindrop Near Vision inlay, ReVision Optics) 2 . A major advantage of corneal inlays is the reversibility of the procedure, as they can be removed if the patients are dissatisfied with their visual outcome 3,4 . However, corneal synthetic inlays may cause biocompatibility related problems with the risk of anterior stromal ulceration and keratolysis, inlay-edge deposits, and interface inflammation 5–8 .…”

Section: Introductionmentioning

confidence: 99%

Corneal remodelling and topography following biological inlay implantation with combined crosslinking in a rabbit model

Damgaard

Liu

Riau

et al. 2019

Sci Rep

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Implantation of biological corneal inlays, derived from small incision lenticule extraction, may be a feasible method for surgical management of refractive and corneal diseases. However, the refractive outcome is dependent on stromal remodelling of both the inlay and recipient stroma. This study aimed to investigate the refractive changes and tissue responses following implantation of 2.5-mm biological inlays with or without corneal collagen crosslinking (CXL) in a rabbit model. Prior to implantation, rotational rheometry demonstrated an almost two-fold increase in corneal stiffness after CXL. After implantation, haze gradually subsided in the CXL-treated inlays (p = 0.001), whereas the untreated inlays preserved their clarity (p = 0.75). In-vivo confocal microscopy revealed reduced keratocyte cell count at the interface of the CXL inlays at week 8. Following initial steepening, regression was observed in anterior mean curvature from week 1 to 12, being most prominent for the non-CXL subgroups (non-CXL: −12.3 ± 2.6D vs CXL: −2.3 ± 4.4D at 90 μm depth, p = 0.03; non-CXL: −12.4 ± 8.0D vs CXL: −5.0 ± 4.0D at 120 μm depth, p = 0.22). Immunohistochemical analysis revealed comparable tissue responses in CXL and untreated subgroups. Our findings suggest that CXL of biological inlays may reduce the time before refractive stabilization, but longer postoperative steroid treatment is necessary in order to reduce postoperative haze.

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AcuFocus Corneal Inlay to Correct Presbyopia Using Femto-LASIK. One Year Results of a Prospective Cohort Study

Abstract: AutoFocus Corneal Inlay (ACI), also known as KAMRA, can provide a safe, effective and, most importantly, reversible treatment for presbyopia in hyperopic, myopic and emmetropic patients.

Cited by 16 publications

References 10 publications

Short-term visual result after simultaneous photorefractive keratectomy and small-aperture cornea inlay implantation

Short-term visual result after simultaneous photorefractive keratectomy and small-aperture cornea inlay implantation

Presbyopia: Effectiveness of correction strategies

Corneal remodelling and topography following biological inlay implantation with combined crosslinking in a rabbit model

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