Refractive corneal inlay for presbyopia in emmetropic patients in Asia: 6-month clinical outcomes

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Abstract

Background

To evaluate the 6-month clinical outcomes of Flexivue Microlens refractive corneal inlay in emmetropic patients in Asia for the surgical compensation of presbyopia.

Methods

In this retrospective study, corneal inlay implantation was done using a femtosecond laser. The follow-up period was 6 months. Near/intermediate/distant visual acuities, refraction, keratometry, defocus curve, wavefront aberrations, contrast sensitivity, Scheimpflug corneal scanning, endothelial cell density, dry eye test, confocal microscopy scanning, and patient questionnaires were evaluated.

Results

The inlay implantation was performed in 21 eyes from June 2015 to April 2017. 6 months after surgery, the uncorrected near visual acuity of the operated eyes increased significantly from 0.55 ± 0.22 logMAR preoperatively to 0.25 ± 0.15 logMAR ( p < 0.05) but mean bilateral uncorrected distant visual acuity did not change significantly ( p = 0.90). Total higher-order aberration and spherical aberration increased, and the contrast sensitivity of the operated eyes decreased. Endothelial cell density and central corneal thickness did not change from preoperative values. Patient satisfaction for near vision was increased 6 months after implantation, and 50.0% of patients were independent of near spectacles. Explantation was done in 2 cases.

Conclusion

The Flexivue Microlens refractive corneal inlay was effective for improving near visual acuity at 6 months follow-up But proportion of spectacle independency and patient satisfaction were lower in this Korean population than in previous reports. Further study with a longer follow-up period is needed.

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Most cited references 37

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The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire.

Sophie E. Moore, Konrad Pesudovs, Colm McAlinden … (2010)

To develop an instrument to measure subjective quality of vision: the Quality of Vision (QoV) questionnaire. A 30-item instrument was designed with 10 symptoms rated in each of three scales (frequency, severity, and bothersome). The QoV was completed by 900 subjects in groups of spectacle wearers, contact lens wearers, and those having had laser refractive surgery, intraocular refractive surgery, or eye disease and investigated with Rasch analysis and traditional statistics. Validity and reliability were assessed by Rasch fit statistics, principal components analysis (PCA), person separation, differential item functioning (DIF), item targeting, construct validity (correlation with visual acuity, contrast sensitivity, total root mean square [RMS] higher order aberrations [HOA]), and test-retest reliability (two-way random intraclass correlation coefficients [ICC] and 95% repeatability coefficients [R(c)]). Rasch analysis demonstrated good precision, reliability, and internal consistency for all three scales (mean square infit and outfit within 0.81-1.27; PCA >60% variance explained by the principal component; person separation 2.08, 2.10, and 2.01 respectively; and minimal DIF). Construct validity was indicated by strong correlations with visual acuity, contrast sensitivity and RMS HOA. Test-retest reliability was evidenced by a minimum ICC of 0.867 and a minimum 95% R(c) of 1.55 units. The QoV Questionnaire consists of a Rasch-tested, linear-scaled, 30-item instrument on three scales providing a QoV score in terms of symptom frequency, severity, and bothersome. It is suitable for measuring QoV in patients with all types of refractive correction, eye surgery, and eye disease that cause QoV problems.

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Relation between corneal innervation with confocal microscopy and corneal sensitivity with noncontact esthesiometry in patients with dry eye.

David Valle, José A Gegúndez, Mónica M Acosta … (2006)

An alteration in corneal innervation has been described in dry eye associated with diabetes mellitus, contact lens use, and LASIK. The purpose of this study was to evaluate whether dry eye not related to Sjögren's syndrome (NSDE) and dry eye related to primary Sjögren's syndrome (PSDE) are associated with an alteration of the corneal nerves and sensation. Twenty-one patients with dry eye (10 NSDE and 11 PSDE) and 20 healthy volunteers were studied. Healthy volunteers were divided into two groups: one younger than 60 years (N or =60). The study of the epithelium, stroma, and subbasal corneal nerves was performed with a confocal microscope. Mechanical, chemical, and thermal sensation was evaluated using the Belmonte noncontact esthesiometer. A statistically significant decrease in the number and density of subbasal nerves (P < 0.0001) and the density of superficial epithelial cells (P < 0.0001) was observed in dry eyes. The number and density of subbasal nerves was higher in the N<60 group. A significant decrease was found with respect to mechanical, chemical, and thermal sensitivity (P < 0.0001). Sensibility was better in the healthy eyes. A strong correlation was found between the density of superficial epithelial cells and the nerves and between the number and density of subbasal nerves and sensation (P < 0.001). The use of confocal microscopy and noncontact esthesiometry allow the detection of the presence of corneal neuropathy in patients with dry eye.

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Corneal nerve structure and function in patients with non-sjogren dry eye: clinical correlations.

Christophe Baudouin, Liang Xu, Antoine Labbe … (2013)

To evaluate the relationship between the in vivo confocal microscopic (IVCM) morphology of subbasal corneal nerves, corneal sensitivity, and clinical parameters in patients with non-Sjögren dry eye disease (NSDD). Forty-three patients with NSDD and 14 healthy age- and sex-matched control subjects were included. Each patient underwent an evaluation of ocular surface disease symptoms using the Ocular Surface Disease Index (OSDI); tear film break-up time (TBUT); corneal and conjunctival staining (Oxford scale); the Schirmer test; corneal sensation testing using the Cochet-Bonnet esthesiometer; and corneal subbasal nerve analysis with IVCM. One eye of each subject was included in the study. Mean corneal sensitivity was significantly lower in the NSDD group as compared with the control group (P = 0.014). Corneal subbasal nerves showed significant changes in NSDD patients as compared with normal subjects: lower density (P < 0.001); increased tortuosity (P < 0.001); number of beadings (P < 0.001); and width (P = 0.041). In patients with NSDD, corneal subbasal nerve density was correlated to age (r = -0.352, P = 0.021); the Oxford scale (r = -0.486, P = 0.01); and central corneal sensitivity (r = 0.383, P = 0.041). The maximum length of nerve fibers within a frame (MaxL) was correlated to the OSDI (r = -0.265, P = 0.019) and the Oxford scale (r = -0.307, P = 0.039). In multivariate analysis after adjustment for age, corneal subbasal nerve density remained correlated to the Oxford score (P < 0.001). The Oxford score was also correlated to central corneal sensitivity (r = -0.304, P = 0.042). NSDD patients have both structural and functional alterations of subbasal corneal nerves and these changes are related to the severity of dry eye.

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Author and article information

Contributors

Gyule Han: akaizuki@gmail.com

Dong Hui Lim: ldhlse@gmail.com

Chan Min Yang: cmyangsmc@gmail.com

Gil Ho Park: gyulehan2@gmail.com

Dae-Young Park: dyparkjung@gmail.com

Hyun Seung Moon: hymoongangnam@gmail.com

Jae Myung Lee: jemyungbageun@gmail.com

Jong Ho Lee: jonghosbse@gmail.com

Tae-Young Chung: +82-2-3410-3548 , tychung@skku.edu

Journal

Journal ID (nlm-ta): BMC Ophthalmol

Journal ID (iso-abbrev): BMC Ophthalmol

Title: BMC Ophthalmology

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2415

Publication date (Electronic): 5 March 2019

Publication date PMC-release: 5 March 2019

Publication date Collection: 2019

Volume: 19

Electronic Location Identifier: 66

Affiliations

[1 ]ISNI 0000 0001 2181 989X, GRID grid.264381.a, Department of Ophthalmology, Samsung Medical Center, , Sungkyunkwan University School of Medicine, ; Seoul, South Korea

[2 ]ISNI 0000 0004 0470 4224, GRID grid.411947.e, Department of Preventive Medicine, Graduate School, , The Catholic University of Korea, ; Seoul, South Korea

[3 ]Cheonan Kim’s Eye Clinic, Cheonan, South Korea

[4 ]Busan Balgeun Sesang Eye Clinic, Busan, South Korea

[5 ]Department of Ophthalmolgy, Jungang Hospital, Jeju, South Korea

[6 ]Gangnam First Eye Clinic, Seoul, South Korea

[7 ]Seoul Balgeun Sesang Eye Clinic, Seoul, South Korea

[8 ]ISNI 0000 0001 2181 989X, GRID grid.264381.a, Department of Ophthalmology, Samsung Medical Center, , Sungkyunkwan University School of Medicine, ; #81 Irwon-ro, Gangnam-gu, Seoul, 06351 South Korea

Article

Publisher ID: 1069

DOI: 10.1186/s12886-019-1069-2

PMC ID: 6399973

PubMed ID: 30836950

SO-VID: 5507f33c-392e-4940-824b-7459c38caef5

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.