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If any of the exclusion criteria were identified at any time during the baseline visit, the visit would be continued as usual, but these children would not be invited to be enrolled in the study. Frames were selected for the children who met eligibility criteria and were willing to participate in PACT; measuring and fitting of the study glasses occurred at the end of the visit.

The randomization visits were also scheduled during this visit. Baseline forms were sent to the coordinating center for independent confirmation of eligibility and randomization. An unmasked investigator clinical coordinator ordered the study lenses based on the measurements and selected frames obtained during the baseline visit.

After study group assignments were made and an identification numbers were issued by the coordinating center, the randomization visit was held. Upon this visit, the child was enrolled officially in PACT. Follow-up visits were scheduled every 6 months for at least 2 years. The main outcome data i. The need for a prescription change was evaluated at all visits based on the criteria detailed in the glasses section see below. Outdoor activity, reading time, time of wearing spectacles, and quality of vision and symptoms while wearing glasses were surveyed at each follow-up visit and telephone contact.

PACT was designed as a double-masked trial to minimize observer and experimenter biases. Masking was achieved with the following steps. All PACT lenses were polycarbonate lenses index 1. The frames were physically comfortable, attractive in appearance, and met the expectations of the subjects.

The power of the lenses was verified by an optometrist before the lenses were mounted. When the lenses were mounted, the powers of the lenses and the progression heights were verified by an optician.

During visits, prescriptions were changed whenever the refraction changed by 0. Glasses were changed for any change of addition of 0. Broken or damaged frames and lenses were replaced.

During half-year visits, if the frame had become too small or the parents demanded a change, the frame was changed. The main outcome measurement in PACT is progression of myopia assessed by cycloplegic autorefraction and axial length measured by Lenstar. Additional outcome measurements include other ocular components. Uncorrected VA, VA with previous glasses, and best corrective VA were tested in both eyes in all subjects using a Snellen visual acuity chart at 4 m.

Snellen acuity was converted to the LogMar scale for enrollment criteria and statistical analysis. Subjective refraction was assessed before cycloplegia, starting with the mean of 5 noncycloplegic autorefractor measurements. Subjective refraction included measurement of the monocular best sphere, cylinder power and axis, binocular balance, and binocular best sphere.

Base-out fusional amplitudes were measured with a phoropter and a 0 D near addition, followed by base-in fusional amplitudes. The blur point, break point, and recovery point were recorded during the measurements.

To avoid accommodative adaptation, we tested the near addition lenses in order from highest to lowest as described in a previous study. After corneal anesthesia induced with proparacaine 0. Worth, TX were administered at 5 minutes a part to induce cycloplegia. Five consecutive, reliable autorefraction measurements were obtained 30 minutes after the third drop was administered. The child was asked to sit in front of the autorefractor Canon RK-F1 and to look at the fixation target, which was designed to obtain the smallest accommodative response.

Ocular components were measured by Lenstar LS Haag-StreitInternational, Koeniz, Switzerland after cycloplegic autorefraction, including axial length, anterior-chamber depth, lens thickness, vitreous-chamber depth and keratometry. The Lenstar LS was suggested for its accuracy and repeatability as evaluated by a previous study. Keratometry was recorded as the greatest keratometry K1 and the least keratometry K2.

Mean keratometry was calculated as the mean of K1 and K2. The next highest 0. Accommodative response was then measured with this ADD. If an accommodative lead was measured, the ADD was decreased, and the accommodative response was measured again until a lag or null accommodation was attained. This ADD was then considered the personalized addition value.

The following elements were included for quality assurance: development of a standard protocol to perform all data collection and follow-up, development of and adherence to a detailed standard operation procedure SOP , standards for training and certification of staff, use of standardized forms and consistent study conditions, uniform patient recruitment criteria, and regular communications between the study investigators.

Data assurance was performed by the PACT investigators, clinical coordinator, and statistics specialist. The investigator ensured that each study member followed the SOP to obtain reliable results. The clinical coordinator was also responsible for the data. Additionally, there were 2 levels for monitoring the data. The 1 st level was that both the electronic files and the hard copy were well-kept and were backed up at each study visit.

The 2 nd level was the input of the data with required double keyboarding. A set of spreadsheets were prepared to store the data. The refraction data, defined as sphere with negative cylinder power and axis, were analyzed by decomposition of the power profile. Pearson correlation coefficients were used to evaluate the correlations among refractive error, ocular components, and age.

All of the statistical analyses were performed using SPSS software, version Progression in PACT was child-based and evaluated by the myopic change magnitude in spherical equivalent cycloplegic autorefraction between the follow-up and baseline data. The change of axial length measured by Lenstar was also evaluated as a parameter of myopia progression. Rate of myopic and axial length change was evaluated by determining the slope for the 3 study groups based on the measurements from baseline and examinations of each follow-up visit.

Standard parametric tests e. A multiple regression model would be used to explore the predictor variables for myopia progression, such as age, sex, baseline refractive error, accommodative lag, phoria level, and reading parameters.

Therefore, we analyzed and present the data of the right eyes only. Most of the subjects , The axis of the cylinder was classified according to a previous study: with the rule WTR was defined as between 0 and The mean difference between the SE of the distance prescription determined by subjective refraction and the cycloplegic autorefraction was minor 0.

Forty-seven percent of children were found to be more myopic by 0. Differences and means of distance prescriptions and cycloplegic autorefraction in right eyes. The axial length of the right eyes Both axial length Fig. There were small but significant differences in corneal radii between the right Keratometry was negatively correlated with age Fig.

In Distribution of addition values in children with personalized addition progressive addition lenses as a function of near phoria. We reported the design, methodology, baseline refraction, and ocular component data of children enrolled in the PACT study. The results reflected the eligibility criteria for this clinical trial, which enrolled children with progressive myopia who will be followed up for at least 2 years.

These data will be used as baseline measurements for later analyses of the progression of myopia during the follow-up of PACT. Because it was a selected population, it does not reflect the actual refraction level for a similar age group.

In a school-based cohort study conducted in China, [ 39 ] myopia was reported to be, on average, Similar to a study by Hasebe et al in Japanese school children, [ 40 ] no significant correlation was found between refraction and age in our study. SE determined by cycloplegic autorefraction was in good agreement with distance prescription, based on subjective refraction.

Subjective refraction required longer procedure times and sustained attention both from the child and the examiner, whereas cycloplegic autorefraction only required brief fixation on a target.

Previous studies also found that few subjects had less myopia with subjective refraction than with cycloplegic autorefraction, particularly in myopes. This difference may be because of changes in higher order aberrations with cycloplegia, in particular the increase in positive spherical error with dilated pupils during cycloplegic autorefraction. Younger children had higher corneal power than older children, but no difference in lens thickness was noted. This finding differed from previous epidemiological studies, which reported that lens thickness decreased with age, whereas corneal power remained stable.

This distribution was comparable to those in the previous studies shown in table 4, except for the COMET 2 study, which enrolled only children with near esophoria. Fusional convergence was reported to decrease and phoria at near to shift toward more exophoria over a period of 10 years in myopic children. Another possible reason for this difference could be the measurement instrument. As we previously noted, [ 29 ] adaptation effects in the vergence system might be observed with the testing of near addition lenses from highest to lowest.

The fusion and phoria measurement results would be affected by the adaptation for the subsequent lenses. Consequently, we measured the accommodation first and then phoria and fusional amplitudes. The phoria and fusional amplitudes measurements might be affected in some subjects by the lens-induced phoria adaptation during the proceeding accommodation testing.

We used the general protocol for all subjects to minimize the intersubject effects, though there might be potential adaptation effects in a subject when using the near addition lenses order. This study provides measurements of myopia using cycloplegic autorefraction and of ocular components using Lenstar measurements.

The baseline data will be used to evaluate the progression of myopia in each treatment group of children. Supplemental Digital Content is available for this article. Medicine Baltimore. Published online Mar Author information Article notes Copyright and License information Disclaimer. Published by Wolters Kluwer Health, Inc. Abstract Background: The aim of this study was to describe the design, methods, and baseline characteristics of children enrolled in the Personalized Addition lenses Clinical Trial PACT.

Methods: PACT is a randomized, controlled, double-masked clinical trial. Results: At baseline, no differences were found between the right and left eyes for any of the main parameters. Conclusion: PACT is a clinical trial evaluating whether myopia progression in children can be slowed by wearing personalized addition PALs compared with fixed addition PALs and SVLs as measured by cycloplegic autorefraction and axial length.

Keywords: myopic children, phoria, progressive addition lenses. Introduction Myopia is one of the most common disorders of the eye, with increasing prevalence in school-age children in Asia, the Americas, and Europe. Study rationale and objectives The PACT study arose from three distinct lines of research: addition lenses for myopia control, addition lenses with vergence compensation, and personalized addition lenses with a balance of accommodation and vergence.

Methods 2. Randomization Children were randomized to 1 of 3 groups i. Implementation Dynamic randomization software was used by the clinical coordinator to generate the random allocation sequence. Open in a separate window. Figure 1.

Overall workflow schematic of the Personalized Addition lenses Clinical Trial follow-up plan. Table 1 Summary of data collection procedures at each study visit.

Masking PACT was designed as a double-masked trial to minimize observer and experimenter biases. Masking was achieved with the following steps 1. All children were identified by an identifying number that was not related to treatment assignment on all study documents. At the baseline visit and all follow-up visits, measurements for glasses were performed for each child as if they were wearing personalized PALs. Randomization assignments were made by the clinical coordinator using dynamic randomization software.

The clinical coordinator kept this information and subsequent information related to the glasses separate from other PACT records.

At each follow-up visit, the study optometrists and the children and their parents were masked as to which group the child belonged. All children in the 3 groups were measured wearing trial frames except for the posture measurements.

At an un-scheduled visit, the study measurements were masked as during follow-up visits if the child needed a new prescription. During data collection, the forms and protocols were standardized and utilized for all children regardless of group assignment.

Data collection forms and examination protocols were standardized and identical for all children regardless of treatment assignment. If any significant symptoms were reported during the study, the clinical coordinator or ophthalmologist would be contacted to address the problem and maintain the mask of the assignment group of the child. Glasses 2. Verification of PALs The power of the lenses was verified by an optometrist before the lenses were mounted.

Guideline for changing the prescription, lenses, and frames During visits, prescriptions were changed whenever the refraction changed by 0. Variables measured The main outcome measurement in PACT is progression of myopia assessed by cycloplegic autorefraction and axial length measured by Lenstar.

Subjective refraction Subjective refraction was assessed before cycloplegia, starting with the mean of 5 noncycloplegic autorefractor measurements. Autorefraction After corneal anesthesia induced with proparacaine 0.

Ocular component measurements Ocular components were measured by Lenstar LS Haag-StreitInternational, Koeniz, Switzerland after cycloplegic autorefraction, including axial length, anterior-chamber depth, lens thickness, vitreous-chamber depth and keratometry.

Quality assurance The following elements were included for quality assurance: development of a standard protocol to perform all data collection and follow-up, development of and adherence to a detailed standard operation procedure SOP , standards for training and certification of staff, use of standardized forms and consistent study conditions, uniform patient recruitment criteria, and regular communications between the study investigators.

Data management The investigator ensured that each study member followed the SOP to obtain reliable results. Statistical analysis 2. Baseline data analyses The refraction data, defined as sphere with negative cylinder power and axis, were analyzed by decomposition of the power profile. Progression analyses Progression in PACT was child-based and evaluated by the myopic change magnitude in spherical equivalent cycloplegic autorefraction between the follow-up and baseline data.

Results 3. Table 2 Basic characteristics of the children enrolled in the study. Figure 2. Baseline distribution of the spherical equivalent of cycloplegic refraction in right eyes. Figure 3.

Figure 4. Figure 5. Ocular components The axial length of the right eyes Figure 6. Multiple testing analyses were carried out using Bonferroni post-hoc corrections. Experiment 1. As determined by repeated measures ANOVA, the main effects on refraction and AL were significant in both treatment groups transected temporal ciliary arteries and sham-operated and times baseline and one week after surgery Table 1A. Additionally, the interaction effects of groups and times on both refraction and AL were also significant Table 1A.

In parallel with the refractive changes, the interocular difference in AL of eyes with transected temporal ciliary arteries 0. The increases in interocular differences were due to myopic shifts in the artery-transected eyes, and not to hyperopic shifts in the fellow control eyes see Supplementary Table S1. Table 1A. View Table. Figure 1. View Original Download Slide. Comparisons of the interocular differences in A refraction and B AL, at the beginning 0 W and end 1 W of the treatment period.

W, week. As determined by repeated measures ANOVA, the main effects on ChT and ChBP were statistically significant in both treatment groups the arterial-transection and sham-operated and at all times baseline, 5 min, and one week after surgery Table 1B.

The baseline ChT in the operated eye was Similarly, ChBP was significantly smaller five minutes after transection of the temporal ciliary arteries In contrast, in the sham-operated group there were no significant differences in ChT and ChBP at either time after treatment Figs.

Table 1B. Hematoxylin and eosin staining revealed no significant changes in retinal structure between the surgery and sham-operated groups at one week Supplementary Figs. S1 A—D. Similarly, a-wave amplitudes were not significantly different between these groups, under either scotopic or photopic conditions Supplementary Figs.

S2 A, S2 B. The b-wave amplitudes in the eyes with transected ciliary arteries were lower than those in the corresponding fellow eyes at stimulus intensities of 0. S2 C, S2 D. However, b-wave amplitudes in the arterial-transection and sham-operated eyes were not significantly different, under either scotopic or photopic conditions Supplementary Figs. One week after transection of the temporal ciliary arteries, the intensities of hypoxia signals were greater in the operated eyes than in the fellow eyes Fig.

Furthermore, the interocular difference in scleral hypoxia signals was much greater in the treated groups 8. Figure 2. A First row, hypoxia signals green. Second row, hypoxia signals green plus DAPI nuclear staining blue.

Third row, higher magnification details of the boxed scleral areas in the second row. Fellow, eyes contralateral to those with either transected temporal ciliary arteries or sham operations; Treated, eyes subjected to either transection of the temporal ciliary arteries or sham surgery. As determined by repeated measures ANOVA, the main effects on refraction and AL were significant in both treatment groups phenylephrine and normal saline groups and times baseline and one week of injections , as were the interaction effects of groups and times on both refraction and AL Table 2A.

Similarly, the interocular difference in AL was greater in the phenylephrine-treated group 0. The increases in interocular difference were due to myopic shifts in the phenylephrine-treated eyes, and not due to hyperopic shifts in the fellow control eyes Supplementary Table S1.

Table 2A. Figure 3. W, week; Fellow, eyes contralateral to those given peribulbar injections of either normal saline or phenylephrine; Treated, eyes given injections of either normal saline or phenylephrine; NS, normal saline; PE, phenylephrine. On the other hand, there were no significant differences in ChT and ChBP between normal saline solution—treated eyes and the corresponding untreated fellow eyes Figs.

However, the ChT of phenylephrine-treated eyes Furthermore, ChT was less in phenylephrine-treated eyes Table 2B. After one week of daily peribulbar phenylephrine injections, the intensity of hypoxia signals in the sclera, as indicated by pimonidazole labeling, was significantly greater in the phenylephrine-treated eyes than in their fellow eyes Fig.

Furthermore, the mean difference in scleral hypoxia signals between the treated and fellow eyes was much larger in phenylephrine-treated eyes 7. Figure 4. A First row , hypoxia signals green. Second row , hypoxia signals green plus DAPI nuclear staining blue. Third row , higher magnification details of the boxed scleral areas in the second row. Fellow: eyes contralateral to those injected with either normal saline or phenylephrine; Treated: eyes injected with either normal saline or phenylephrine; NS, normal saline; PE, phenylephrine.

Experiment 2. Similarly, the interaction effects of groups and times on refraction and AL were also significant Table 3A. In parallel, the interocular difference in AL between the quinpirole-injected FDM and the fellow eyes 0. The increases in interocular difference were due to myopic shifts in the quinpirole-injected FDM eyes, and not due to hyperopic shifts in the fellow control eyes Supplementary Table S1. Table 3A. Figure 5. Comparison of the interocular differences in A refraction and B AL at the beginning 0 W and end 2 W of the treatment period.

Table 3B. This increase in hypoxia signals was enhanced further by quinpirole injection. In FDM eyes, quinpirole induced a large increase in the interocular difference of scleral hypoxia signals expression.

Figure 6. First row , hypoxia signals green. Third row , higher magnification of the boxed scleral areas in the second row. Choroidal structure and vasculature are critical factors that are closely linked with changes in scleral oxygenation and biochemistry, culminating in the changes in eye size and refractive state associated with emmetropization.

Overall, these findings agree with the hypothesis that the development of myopia in guinea pigs is mediated by the reduction of ChBP. The possibility remains, however, that both of these could be caused by other factors. For instance, the effects of arterial transection and adrenergic agonist treatment on ChBP and myopia development could be mediated independently, either by direct responses to the treatments themselves or via actions on other tissues such as the RPE and non-vascular elements of the choroid.

Also, quinpirole injections during myopia induction further augmented these changes. Yuan et al. These findings support an association of scleral myofibroblast transdifferentiation with the development of myopia in guinea pigs. This may be due to the differences in duration of form deprivation.

Also, this suggests that ascorbic acid itself might modulate myopia development in the guinea pig, independently of the drug for which it served as vehicle. The role of hypoxia in the cause of various systemic diseases has been well documented. Choroidal blood flow is a major factor that impacts the oxygenation of the adjacent scleral tissue. Interestingly, the significant reductions in ChBP, five minutes after transection of the temporal ciliary arteries, disappeared after one week, although scleral hypoxia was still evident at that time.

This suggests that even though the choroidal vascular changes are transient, as indicated by the recovery from reduced ChBP shortly after the surgery, the effect on the adjacent tissue is longer lasting. The transient reduction of ChBP might affect the scleral biochemistry by impeding ECM production, rendering the sclera thinner and more distensible, which could eventually result in excessive eye enlargement. This hypothesis is consistent with the observed onset of the myopic shift and the increased AL, which happened one week after the transection of the ciliary arteries.

The impacts of hypoxia on scleral biochemistry and myopia development were consistent with results of our earlier study, which implicated hypoxia as a key modulator of scleral ECM composition and structure during myopia development. This change was accompanied by reduced synthesis of type I collagen, which contributed to scleral ECM remodeling and subsequent scleral thinning and myopia induction. Ocular growth relies on active visual signals in response to sharp images on the retina; the absence of sufficient exposure to detailed images results in refractive errors.

On the other hand, hyperopic defocus images of distant objects focused behind the retina , induced with a negative lens, results in an increase in axial elongation and a myopic shift in refraction. Simultaneously, myopic defocus leads to choroidal thickening, while hyperopic defocus leads to choroidal thinning; furthermore, both the rates of ChT and ocular elongation return to normal after removal of the imposed defocus.

Furthermore, the time course of these changes in ChT are fast, compared to those of the associated changes in refractive error; 48 , 49 this indicates that choroidal thickness can potentially serve as an early biomarker of refractive change and ocular growth. In addition to the choroidal thickening and thinning that move the retina towards the image focal plane in response to defocus, the choroid has the capacity to regulate the delivery of bioactive molecules that can be released from the retina, retinal pigment epithelium, and choroid to the sclera.

In contrast, thinner choroids may facilitate the access of molecules to the sclera, accelerate scleral ECM remodeling, and eventually promote myopia development. Because the choroid is positioned between the retina and the sclera, it can be presumed that this vascular tissue relays defocus signals that could be critical in ocular growth to the adjacent ocular structures.

Based on this assumption, the findings of our study suggest that the myopiagenic stimulus from the retina passes through the choroid, resulting in reductions in choroidal thickness and blood flow. In the present study, we obtained experimental support for this hypothesis based on surgical and pharmacological interventions that attenuated ChBP and induced choroidal thinning and scleral hypoxia, followed by excessive axial elongation and myopia progression.

Thus our findings support a critical role of ChBP in the development and the progression of myopia in guinea pigs. Stell Cumming School of Medicine, University of Calgary for critical comments and editorial support in manuscript preparation. Disclosure: X. Zhou , None; S. Zhang , None; F. Yang, None; Y. Yang , None; Q. Huang , None; C. Huang , None; J. Qu , None; X. Zhou , None.

The epidemics of myopia: Aetiology and prevention. Prog Retin Eye Res. Visual consequences of refractive errors in the general population. Prevalence and causes of low vision and blindness in a Japanese adult population: the Tajimi Study. Cho P, Cheung SW. Invest Ophthalmol Vis Sci. Structural and ultrastructural changes to the sclera in a mammalian model of high myopia.

Scleral Thickness in Chinese Eyes. The sclera and myopia. Exp Eye Res. Scleral remodeling during the development of and recovery from axial myopia in the tree shrew. Decreased proteoglycan synthesis associated with form deprivation myopia in mature primate eyes. Collagen gene expression and the altered accumulation of scleral collagen during the development of high myopia.

J Biol Chem. Scleral hypoxia is a target for myopia control.

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