Myopia control with novel central and peripheral plus contact lenses and extended depth of focus contact lenses: 2 year results from a randomised clinical trial

Purpose We aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended depth of focus with better global retinal image quality for points on, and anterior to, the retina and degraded for points posterior to...

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Vydáno v:Ophthalmic & physiological optics Ročník 39; číslo 4; s. 294 - 307
Hlavní autoři: Sankaridurg, Padmaja, Bakaraju, Ravi C, Naduvilath, Thomas, Chen, Xiang, Weng, Rebecca, Tilia, Daniel, Xu, Pauline, Li, Wayne, Conrad, Fabian, Smith, Earl L, Ehrmann, Klaus
Médium: Journal Article
Jazyk:angličtina
Vydáno: England Wiley Subscription Services, Inc 01.07.2019
John Wiley and Sons Inc
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ISSN:0275-5408, 1475-1313, 1475-1313
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Abstract Purpose We aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended depth of focus with better global retinal image quality for points on, and anterior to, the retina and degraded for points posterior to the retina. Methods Children (n = 508, 8–13 years) with cycloplegic spherical equivalent (SE) −0.75 to −3.50D were enrolled in a prospective, double blind trial and randomised to one of five groups: (1) single vision, silicone hydrogel (SH) CL; (2) two groups wearing SH CL that imposed myopic defocus across peripheral and central retina (test CL I and II; +1.00D centrally and +2.50 and +1.50 for CL I and II at 3 mm semi‐chord respectively); and (3) two groups wearing extended depth of focus (EDOF) hydrogel CL incorporating higher order aberrations to modulate retinal image quality (test CL III and IV; extended depth of focus of up to +1.75D and +2.50D respectively). Cycloplegic autorefraction and axial length (AL) measurements were conducted at six monthly intervals. Compliance to lens wear was assessed with a diary and collected at each visit. Additionally, subjective responses to various aspects of lens wear were assessed. The trial commenced in February 2014 and was terminated in January 2017 due to site closure. Myopia progression over time between groups was compared using linear mixed models and where needed post hoc analysis with Bonferroni corrections conducted. Results Myopia progressed with control CL −1.12 ± 0.51D/0.58 ± 0.27 mm for SE/AL at 24 months. In comparison, all test CL had reduced progression with SE/AL ranging from −0.78D to −0.87D/0.41–0.46 mm at 24 months (AL: p < 0.05 for all test CL; SE p < 0.05 for test CL III and IV) and represented a reduction in axial length elongation of about 22% to 32% and reduction in spherical equivalent of 24% to 32%. With test CL, a greater slowing ranging from 26% to 43% was observed in compliant wearers (≥6 days per week; Control CL: −0.64D/0.30 mm and −1.14D/0.58 mm vs test CL: −0.42D to −0.47D/0.12–0.18 mm and −0.70 to −0.81D/0.19–0.25 mm at 12 and 24 months respectively). Conclusions Contact lenses that either imposed myopic defocus at the retina or modulated retinal image quality resulted in a slower progression of myopia with greater efficacy seen in compliant wearers. Importantly, there was no difference in the myopia control provided by either of these strategies.
AbstractList PurposeWe aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended depth of focus with better global retinal image quality for points on, and anterior to, the retina and degraded for points posterior to the retina.MethodsChildren (n = 508, 8–13 years) with cycloplegic spherical equivalent (SE) −0.75 to −3.50D were enrolled in a prospective, double blind trial and randomised to one of five groups: (1) single vision, silicone hydrogel (SH) CL; (2) two groups wearing SH CL that imposed myopic defocus across peripheral and central retina (test CL I and II; +1.00D centrally and +2.50 and +1.50 for CL I and II at 3 mm semi‐chord respectively); and (3) two groups wearing extended depth of focus (EDOF) hydrogel CL incorporating higher order aberrations to modulate retinal image quality (test CL III and IV; extended depth of focus of up to +1.75D and +2.50D respectively). Cycloplegic autorefraction and axial length (AL) measurements were conducted at six monthly intervals. Compliance to lens wear was assessed with a diary and collected at each visit. Additionally, subjective responses to various aspects of lens wear were assessed. The trial commenced in February 2014 and was terminated in January 2017 due to site closure. Myopia progression over time between groups was compared using linear mixed models and where needed post hoc analysis with Bonferroni corrections conducted.ResultsMyopia progressed with control CL −1.12 ± 0.51D/0.58 ± 0.27 mm for SE/AL at 24 months. In comparison, all test CL had reduced progression with SE/AL ranging from −0.78D to −0.87D/0.41–0.46 mm at 24 months (AL: p < 0.05 for all test CL; SE p < 0.05 for test CL III and IV) and represented a reduction in axial length elongation of about 22% to 32% and reduction in spherical equivalent of 24% to 32%. With test CL, a greater slowing ranging from 26% to 43% was observed in compliant wearers (≥6 days per week; Control CL: −0.64D/0.30 mm and −1.14D/0.58 mm vs test CL: −0.42D to −0.47D/0.12–0.18 mm and −0.70 to −0.81D/0.19–0.25 mm at 12 and 24 months respectively).ConclusionsContact lenses that either imposed myopic defocus at the retina or modulated retinal image quality resulted in a slower progression of myopia with greater efficacy seen in compliant wearers. Importantly, there was no difference in the myopia control provided by either of these strategies.
We aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended depth of focus with better global retinal image quality for points on, and anterior to, the retina and degraded for points posterior to the retina.PURPOSEWe aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended depth of focus with better global retinal image quality for points on, and anterior to, the retina and degraded for points posterior to the retina.Children (n = 508, 8-13 years) with cycloplegic spherical equivalent (SE) -0.75 to -3.50D were enrolled in a prospective, double blind trial and randomised to one of five groups: (1) single vision, silicone hydrogel (SH) CL; (2) two groups wearing SH CL that imposed myopic defocus across peripheral and central retina (test CL I and II; +1.00D centrally and +2.50 and +1.50 for CL I and II at 3 mm semi-chord respectively); and (3) two groups wearing extended depth of focus (EDOF) hydrogel CL incorporating higher order aberrations to modulate retinal image quality (test CL III and IV; extended depth of focus of up to +1.75D and +2.50D respectively). Cycloplegic autorefraction and axial length (AL) measurements were conducted at six monthly intervals. Compliance to lens wear was assessed with a diary and collected at each visit. Additionally, subjective responses to various aspects of lens wear were assessed. The trial commenced in February 2014 and was terminated in January 2017 due to site closure. Myopia progression over time between groups was compared using linear mixed models and where needed post hoc analysis with Bonferroni corrections conducted.METHODSChildren (n = 508, 8-13 years) with cycloplegic spherical equivalent (SE) -0.75 to -3.50D were enrolled in a prospective, double blind trial and randomised to one of five groups: (1) single vision, silicone hydrogel (SH) CL; (2) two groups wearing SH CL that imposed myopic defocus across peripheral and central retina (test CL I and II; +1.00D centrally and +2.50 and +1.50 for CL I and II at 3 mm semi-chord respectively); and (3) two groups wearing extended depth of focus (EDOF) hydrogel CL incorporating higher order aberrations to modulate retinal image quality (test CL III and IV; extended depth of focus of up to +1.75D and +2.50D respectively). Cycloplegic autorefraction and axial length (AL) measurements were conducted at six monthly intervals. Compliance to lens wear was assessed with a diary and collected at each visit. Additionally, subjective responses to various aspects of lens wear were assessed. The trial commenced in February 2014 and was terminated in January 2017 due to site closure. Myopia progression over time between groups was compared using linear mixed models and where needed post hoc analysis with Bonferroni corrections conducted.Myopia progressed with control CL -1.12 ± 0.51D/0.58 ± 0.27 mm for SE/AL at 24 months. In comparison, all test CL had reduced progression with SE/AL ranging from -0.78D to -0.87D/0.41-0.46 mm at 24 months (AL: p < 0.05 for all test CL; SE p < 0.05 for test CL III and IV) and represented a reduction in axial length elongation of about 22% to 32% and reduction in spherical equivalent of 24% to 32%. With test CL, a greater slowing ranging from 26% to 43% was observed in compliant wearers (≥6 days per week; Control CL: -0.64D/0.30 mm and -1.14D/0.58 mm vs test CL: -0.42D to -0.47D/0.12-0.18 mm and -0.70 to -0.81D/0.19-0.25 mm at 12 and 24 months respectively).RESULTSMyopia progressed with control CL -1.12 ± 0.51D/0.58 ± 0.27 mm for SE/AL at 24 months. In comparison, all test CL had reduced progression with SE/AL ranging from -0.78D to -0.87D/0.41-0.46 mm at 24 months (AL: p < 0.05 for all test CL; SE p < 0.05 for test CL III and IV) and represented a reduction in axial length elongation of about 22% to 32% and reduction in spherical equivalent of 24% to 32%. With test CL, a greater slowing ranging from 26% to 43% was observed in compliant wearers (≥6 days per week; Control CL: -0.64D/0.30 mm and -1.14D/0.58 mm vs test CL: -0.42D to -0.47D/0.12-0.18 mm and -0.70 to -0.81D/0.19-0.25 mm at 12 and 24 months respectively).Contact lenses that either imposed myopic defocus at the retina or modulated retinal image quality resulted in a slower progression of myopia with greater efficacy seen in compliant wearers. Importantly, there was no difference in the myopia control provided by either of these strategies.CONCLUSIONSContact lenses that either imposed myopic defocus at the retina or modulated retinal image quality resulted in a slower progression of myopia with greater efficacy seen in compliant wearers. Importantly, there was no difference in the myopia control provided by either of these strategies.
We aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended depth of focus with better global retinal image quality for points on, and anterior to, the retina and degraded for points posterior to the retina. Children (n = 508, 8-13 years) with cycloplegic spherical equivalent (SE) -0.75 to -3.50D were enrolled in a prospective, double blind trial and randomised to one of five groups: (1) single vision, silicone hydrogel (SH) CL; (2) two groups wearing SH CL that imposed myopic defocus across peripheral and central retina (test CL I and II; +1.00D centrally and +2.50 and +1.50 for CL I and II at 3 mm semi-chord respectively); and (3) two groups wearing extended depth of focus (EDOF) hydrogel CL incorporating higher order aberrations to modulate retinal image quality (test CL III and IV; extended depth of focus of up to +1.75D and +2.50D respectively). Cycloplegic autorefraction and axial length (AL) measurements were conducted at six monthly intervals. Compliance to lens wear was assessed with a diary and collected at each visit. Additionally, subjective responses to various aspects of lens wear were assessed. The trial commenced in February 2014 and was terminated in January 2017 due to site closure. Myopia progression over time between groups was compared using linear mixed models and where needed post hoc analysis with Bonferroni corrections conducted. Myopia progressed with control CL -1.12 ± 0.51D/0.58 ± 0.27 mm for SE/AL at 24 months. In comparison, all test CL had reduced progression with SE/AL ranging from -0.78D to -0.87D/0.41-0.46 mm at 24 months (AL: p < 0.05 for all test CL; SE p < 0.05 for test CL III and IV) and represented a reduction in axial length elongation of about 22% to 32% and reduction in spherical equivalent of 24% to 32%. With test CL, a greater slowing ranging from 26% to 43% was observed in compliant wearers (≥6 days per week; Control CL: -0.64D/0.30 mm and -1.14D/0.58 mm vs test CL: -0.42D to -0.47D/0.12-0.18 mm and -0.70 to -0.81D/0.19-0.25 mm at 12 and 24 months respectively). Contact lenses that either imposed myopic defocus at the retina or modulated retinal image quality resulted in a slower progression of myopia with greater efficacy seen in compliant wearers. Importantly, there was no difference in the myopia control provided by either of these strategies.
Purpose We aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended depth of focus with better global retinal image quality for points on, and anterior to, the retina and degraded for points posterior to the retina. Methods Children (n = 508, 8–13 years) with cycloplegic spherical equivalent (SE) −0.75 to −3.50D were enrolled in a prospective, double blind trial and randomised to one of five groups: (1) single vision, silicone hydrogel (SH) CL; (2) two groups wearing SH CL that imposed myopic defocus across peripheral and central retina (test CL I and II; +1.00D centrally and +2.50 and +1.50 for CL I and II at 3 mm semi‐chord respectively); and (3) two groups wearing extended depth of focus (EDOF) hydrogel CL incorporating higher order aberrations to modulate retinal image quality (test CL III and IV; extended depth of focus of up to +1.75D and +2.50D respectively). Cycloplegic autorefraction and axial length (AL) measurements were conducted at six monthly intervals. Compliance to lens wear was assessed with a diary and collected at each visit. Additionally, subjective responses to various aspects of lens wear were assessed. The trial commenced in February 2014 and was terminated in January 2017 due to site closure. Myopia progression over time between groups was compared using linear mixed models and where needed post hoc analysis with Bonferroni corrections conducted. Results Myopia progressed with control CL −1.12 ± 0.51D/0.58 ± 0.27 mm for SE/AL at 24 months. In comparison, all test CL had reduced progression with SE/AL ranging from −0.78D to −0.87D/0.41–0.46 mm at 24 months (AL: p < 0.05 for all test CL; SE p < 0.05 for test CL III and IV) and represented a reduction in axial length elongation of about 22% to 32% and reduction in spherical equivalent of 24% to 32%. With test CL, a greater slowing ranging from 26% to 43% was observed in compliant wearers (≥6 days per week; Control CL: −0.64D/0.30 mm and −1.14D/0.58 mm vs test CL: −0.42D to −0.47D/0.12–0.18 mm and −0.70 to −0.81D/0.19–0.25 mm at 12 and 24 months respectively). Conclusions Contact lenses that either imposed myopic defocus at the retina or modulated retinal image quality resulted in a slower progression of myopia with greater efficacy seen in compliant wearers. Importantly, there was no difference in the myopia control provided by either of these strategies.
Author Naduvilath, Thomas
Tilia, Daniel
Weng, Rebecca
Li, Wayne
Xu, Pauline
Sankaridurg, Padmaja
Bakaraju, Ravi C
Conrad, Fabian
Ehrmann, Klaus
Chen, Xiang
Smith, Earl L
AuthorAffiliation 3 State Key Laboratory of Ophthalmology Zhongshan Ophthalmic Centre Sun Yet Sen University Guangzhou China
1 Brien Holden Vision Institute Sydney Australia
4 College of Optometry University of Houston Houston USA
2 School of Optometry and Vision Science University of New South Wales Sydney Australia
AuthorAffiliation_xml – name: 1 Brien Holden Vision Institute Sydney Australia
– name: 4 College of Optometry University of Houston Houston USA
– name: 2 School of Optometry and Vision Science University of New South Wales Sydney Australia
– name: 3 State Key Laboratory of Ophthalmology Zhongshan Ophthalmic Centre Sun Yet Sen University Guangzhou China
Author_xml – sequence: 1
  givenname: Padmaja
  orcidid: 0000-0001-5537-6193
  surname: Sankaridurg
  fullname: Sankaridurg, Padmaja
  email: p.sankaridurg@brienholdenvision.org
  organization: University of New South Wales
– sequence: 2
  givenname: Ravi C
  surname: Bakaraju
  fullname: Bakaraju, Ravi C
  organization: University of New South Wales
– sequence: 3
  givenname: Thomas
  surname: Naduvilath
  fullname: Naduvilath, Thomas
  organization: University of New South Wales
– sequence: 4
  givenname: Xiang
  surname: Chen
  fullname: Chen, Xiang
  organization: Sun Yet Sen University
– sequence: 5
  givenname: Rebecca
  surname: Weng
  fullname: Weng, Rebecca
  organization: Brien Holden Vision Institute
– sequence: 6
  givenname: Daniel
  surname: Tilia
  fullname: Tilia, Daniel
  organization: Brien Holden Vision Institute
– sequence: 7
  givenname: Pauline
  surname: Xu
  fullname: Xu, Pauline
  organization: Brien Holden Vision Institute
– sequence: 8
  givenname: Wayne
  surname: Li
  fullname: Li, Wayne
  organization: Brien Holden Vision Institute
– sequence: 9
  givenname: Fabian
  surname: Conrad
  fullname: Conrad, Fabian
  organization: Brien Holden Vision Institute
– sequence: 10
  givenname: Earl L
  surname: Smith
  fullname: Smith, Earl L
  organization: University of Houston
– sequence: 11
  givenname: Klaus
  surname: Ehrmann
  fullname: Ehrmann, Klaus
  organization: University of New South Wales
BackLink https://www.ncbi.nlm.nih.gov/pubmed/31180155$$D View this record in MEDLINE/PubMed
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Issue 4
Keywords myopia
progression
extended depth of focus contact lenses
central and peripheral plus contact lenses
Language English
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2019 The Authors. Ophthalmic and Physiological Optics published by John Wiley & Sons Ltd on behalf of College of Optometrists.
This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
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  article-title: Clinical evaluation of a dual-focus myopia control 1 day soft contact lens - 2-year results
  publication-title: Optom Vis Sci
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  doi: 10.1097/OPX.0000000000000036
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Snippet Purpose We aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided...
We aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended...
PurposeWe aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided...
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wiley
SourceType Open Access Repository
Aggregation Database
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StartPage 294
SubjectTerms Adolescent
Analysis of Variance
central and peripheral plus contact lenses
Child
Clinical trials
Contact lenses
Contact Lenses, Hydrophilic
Double-Blind Method
extended depth of focus contact lenses
Female
Humans
Hydrogels
Male
Myopia
Myopia, Degenerative - prevention & control
Myopia, Degenerative - therapy
Original
progression
Prospective Studies
Prosthesis Design
Retina
Silicones
Title Myopia control with novel central and peripheral plus contact lenses and extended depth of focus contact lenses: 2 year results from a randomised clinical trial
URI https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fopo.12621
https://www.ncbi.nlm.nih.gov/pubmed/31180155
https://www.proquest.com/docview/2245952164
https://www.proquest.com/docview/2246908155
https://pubmed.ncbi.nlm.nih.gov/PMC6851825
Volume 39
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