A Randomized Trial of the Effect of Single-Vision vs. Bifocal Lenses on Myopia Progression in Children with Esophoria

BACKGROUND Hyperopia occurs due to insufficient ocular growth and a failure to emmetropize in childhood. In anisohyperopia, it is unclear why one eye may remain hyperopic while the fellow eye grows toward an emmetropic state. Animal studies have shown that manipulating peripheral defocus through optical means while simultaneously providing correct axial focus can either discourage or encourage axial eye growth to effectively treat myopia or hyperopia, respectively. Myopia progression and axial eye growth can be significantly reduced in children and adolescents through the use of multifocal contact lenses. These contact lenses correct distance central myopia while simultaneously imposing relative peripheral myopic defocus. The effect of correcting distance central hyperopia while simultaneously imposing relative peripheral hyperopic defocus is yet to be elucidated in humans. OBJECTIVE The objective of our study is to understand the natural progression of axial eye growth and refractive error in hyperopes and anisohyperopes and to establish whether axial eye growth and refractive error can be modified using multifocal contact lenses in hyperopes and anisohyperopes. METHODS There are 3 elements to the program of research. First, the natural progression of axial eye growth and refractive error will be measured in spectacle-wearing hyperopic and anisohyperopic subjects aged between 5 and <20 years. In other words, the natural growth of the eye will be followed without any intervention. Second, as a paired-eye control study, anisohyperopes aged between 8 and <16 years will be fitted with a center-near multifocal design contact lens in their more hyperopic eye and a single-vision contact lens in the fellow eye if required. The progression of axial eye growth and refractive error will be measured and compared. Third, subjects aged between 8 and <16 years with similar levels of hyperopia in each eye will be fitted with center-near multifocal design contact lenses in each eye; the progression of axial eye growth and refractive error in these subjects will be measured and compared with those of subjects in the natural progression study. RESULTS Recruitment commenced on 6 June 2016 and was completed on 8 April 2017. We estimate the data collection to be completed by April 2020. CONCLUSIONS This trial will establish whether axial eye growth can be accelerated in children with hyperopia by imposing relative peripheral hyperopic defocus using center-near multifocal contact lenses. CLINICALTRIAL ClinicalTrials.gov NCT02686879; https://clinicaltrials.gov/ct2/show/NCT02686879 (Archived by Webcite at http://www.webcitation.org/71o5p3fD2) REGISTERED REPORT IDENTIFIER RR1-10.2196/9320

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One-year myopia control efficacy of spectacle lenses with aspherical lenslets

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2020-318367 ◽

2021 ◽

pp. bjophthalmol-2020-318367

Author(s):

Jinhua Bao ◽

Adeline Yang ◽

Yingying Huang ◽

Xue Li ◽

Yiguo Pan ◽

...

Keyword(s):

Control Efficacy ◽

Myopia Progression ◽

Corrected Visual Acuity ◽

Single Vision ◽

Spherical Equivalent Refraction ◽

Registration Number ◽

The Mean ◽

One Year ◽

To Receive ◽

Myopia Control

AimsTo evaluate the 1-year efficacy of two new myopia control spectacle lenses with lenslets of different asphericity.MethodsOne hundred seventy schoolchildren aged 8–13 years with myopia of −0.75 D to −4.75 D were randomised to receive spectacle lenses with highly aspherical lenslets (HAL), spectacle lenses with slightly aspherical lenslets (SAL), or single-vision spectacle lenses (SVL). Cycloplegic autorefraction (spherical equivalent refraction (SER)), axial length (AL) and best-corrected visual acuity (BCVA) were measured at baseline and 6-month intervals. Adaptation and compliance questionnaires were administered during all visits.ResultsAfter 1 year, the mean changes in the SER (±SE) and AL (±SE) in the SVL group were −0.81±0.06 D and 0.36±0.02 mm. Compared with SVL, the myopia control efficacy measured using SER was 67% (difference of 0.53 D) for HAL and 41% (difference of 0.33 D) for SAL, and the efficacy measured using AL was 64% (difference of 0.23 mm) for HAL and 31% (difference of 0.11 mm) for SAL (all p<0.01). HAL resulted in significantly greater myopia control than SAL for SER (difference of 0.21 D, p<0.001) and AL (difference of 0.12 mm, p<0.001). The mean BCVA (−0.01±0.1 logMAR, p=0.22) and mean daily wearing time (13.2±2.6 hours, p=0.26) were similar among the three groups. All groups adapted to their lenses with no reported adverse events, complaints or discomfort.ConclusionsSpectacle lenses with aspherical lenslets effectively slow myopia progression and axial elongation compared with SVL. Myopia control efficacy increased with lenslet asphericity.Trial registration numberChiCTR1800017683.

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To Correct or Not Correct? Actual Evidence, Controversy and the Questions That Remain Open

Journal of Clinical Medicine ◽

10.3390/jcm9061975 ◽

2020 ◽

Vol 9 (6) ◽

pp. 1975

Author(s):

Miguel García García ◽

Katharina Breher ◽

Arne Ohlendorf ◽

Siegfried Wahl

Keyword(s):

Basic Research ◽

Control Group ◽

Myopia Progression ◽

Ethical Implications ◽

Eye Growth ◽

Single Vision ◽

Full Correction ◽

New Guidelines ◽

Lens Wear ◽

Myopia Control

Clinical studies and basic research have attempted to establish a relationship between myopia progression and single vision spectacle wear, albeit with unclear results. Single vision spectacle lenses are continuously used as the control group in myopia control trials. Hence, it is a matter of high relevance to investigate further whether they yield any shift on the refractive state, which could have been masked by being used as a control. In this review, eye development in relation to eyes fully corrected versus those under-corrected is discussed, and new guidelines are provided for the analysis of structural eye changes due to optical treatments. These guidelines are tested and optimised, while ethical implications are revisited. This newly described methodology can be translated to larger clinical trials, finally exerting the real effect of full correction via single vision spectacle lens wear on eye growth and myopia progression.

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A Randomized Trial of the Effect of Soft Contact Lenses on Myopia Progression in Children

Investigative Opthalmology & Visual Science ◽

10.1167/iovs.08-2067 ◽

2008 ◽

Vol 49 (11) ◽

pp. 4702 ◽

Cited By ~ 67

Author(s):

Jeffrey J. Walline ◽

Lisa A. Jones ◽

Loraine Sinnott ◽

Ruth E. Manny ◽

Amber Gaume ◽

...

Keyword(s):

Randomized Trial ◽

Contact Lenses ◽

Soft Contact ◽

Myopia Progression ◽

Soft Contact Lenses

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Ocular and corneal aberrations changes in controlled randomized clinical trial MiSight® Assessment Study Spain (MASS)

BMC Ophthalmology ◽

10.1186/s12886-021-01865-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Daniela Lopes-Ferreira ◽

Alicia Ruiz-Pomeda ◽

Belén Peréz-Sanchéz ◽

António Queirós ◽

César Villa-Collar

Keyword(s):

Clinical Trial ◽

Contact Lenses ◽

Spherical Aberration ◽

High Order ◽

Control Group ◽

Myopia Progression ◽

Corneal Aberrations ◽

Single Vision ◽

Control Versus ◽

Low Order

Abstract Background To compare ocular and corneal inherent aberrations in the naked eyes of randomly selected children fitted with MiSight contact lenses (CL) for myopia control, versus children corrected with single-vision spectacles (control), over a 24-months period. Methods Children aged 8 to 12 years, with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were randomly assigned to the lens study group (MiSight) or the control group (single-vision spectacles). The root mean square aberration (RMS) was determined as corneal (RMS_C), corneal high order RMS (HO_RMS_C), corneal low order RMS (LO_RMS_C), ocular (total) RMS (RMS_T), ocular high order RMS (HO_RMS_T), ocular low order RMS (LO_RMS_T), corneal spherical aberration (SA_C) and ocular SA (SA_T) were calculated by aberrometry measures at the baseline, on 12-months and 24-months visits. A 5 mm diameter was defined for the analysis in all visits for all subjects. Only the dominant eye was analyzed. Results Seventy-four subjects completed the clinical trial: 41 subjects from the MiSight group (age: 11.01 ± 1.23 years) and 33 from the single-vision group (age: 10.12 ± 1.38 years). RMS_T significantly changed (0.57 ± 0.20 µm, p = 0.029) after 24-months in the control group. In the MiSight group no significant changes were registered (p > 0.05). The SA_C and SA_T did not reveal significant changes between visits or between groups (p > 0.05). Conclusions Along 2 years, MiSight CL did not induce significant changes in RMS of anterior cornea or total ocular RMS. Contrary, in control group the RMS_T significantly changed as response of greater eye growth and myopia progression. The results obtained in present study allow to predict corneal or total aberration changes, in children, in response of wearing of MiSight lens along the time. Trial registration : ClinicalTrials.gov Identifier: NCT01917110.

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