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PurposeTo evaluate the effects of 0.01% and 0.02% atropine eye drops on myopia progression, pupil diameter and accommodative amplitude in myopic children.MethodsA cohort study assessed 400 myopic children divided into three groups: 138 and 142 children were randomised to use either 0.02% or 0.01% atropine eye drops, respectively. They wore single-vision (SV) spectacles, with one drop of atropine eye drop applied to both eyes once nightly. Control children (n=120) only wore SV spectacles. Repeated measurements of spherical equivalent refractive errors (SERs), axial length (AL), pupil diameter and accommodative amplitude were performed at baseline, and 4, 8 and 12 months after treatment.ResultsAfter 12 months, the SER change was −0.38±0.35D, −0.47±0.45D, −0.70±0.60D and AL change was 0.30±0.21 mm, 0.37±0.22 mm, 0.46±0.35 mm in the 0.02%, 0.01% atropine and control groups, respectively. There were significant differences in the change in AL and SER between three groups (all p<0.001). Between baseline and the 12-month visit, the overall change in accommodative amplitude was 1.50±0.25D, 1.61±0.31D and change in pupil diameter was 0.78±0.42 mm, 0.69±0.39 mm, with 0.02% and 0.01% atropine, respectively. Accommodative amplitude significantly decreased and pupil diameter significantly increased in two atropine groups (all p<0.001). Moreover, there was no statistical difference in the change difference in accommodative amplitude and pupil diameter between two atropine groups (p=0.24, p=0.38), whereas the accommodative amplitude (p=0.45) and pupil diameter (p=0.39) in the control group remained stable.Conclusions0.02% atropine eye drops had a better effect on myopia progression than 0.01% atropine, but 0.02% and 0.01% atropine showed similar effects on pupil diameter and accommodative amplitude after 12 months of treatment.Trial registration numberChiCTR-IPD-16008844.

PurposeTo investigate the effect of low-intensity red-light (LRL) therapy on myopic control and the response after its cessation.MethodsA prospective clinical trial. One hundred two children aged 6 to 13 with myopia were included in the LRL group (n = 51) and the single-focus spectacles (SFS) group (n = 51). In LRL group, subjects wore SFS and received LRL therapy provided by a laser device that emitted red-light of 635 nm and power of 0.35 ± 0.02 mW. One year after the control trial, LRL therapy was stopped for 3 months. The outcomes mainly included axial length (AL), spherical equivalent refraction (SER), subfoveal choroidal thickness (SFCT), and accommodative function.ResultsAfter 12 months of therapy, 46 children in the LRL group and 40 children in the SFS group completed the trial. AL elongation and myopic progression were 0.01 mm (95%CI: − 0.05 to 0.07 mm) and 0.05 D (95%CI: − 0 .08 to 0.19 D) in the LRL group, which were less than 0.39 mm (95%CI: 0.33 to 0.45 mm) and − 0.64 D (95%CI: − 0.78 to − 0.51 D) in the SFS group (p < 0.05). The change of SFCT in the LRL group was greater than that in the SFS group (p < 0.05). Accommodative response and positive relative accommodation in the LRL group were more negative than those in the SFS group (p < 0.05). Forty-two subjects completed the observation of LRL cessation, AL and SER increased by 0.16 mm (95%CI: 0.11 to 0.22 mm) and − 0.20 D (95%CI: − 0.26 to − 0.14 D) during the cessation (p < 0.05), and SFCT returned to baseline (p > 0.05).ConclusionsLRL is an effective measure for preventing and controlling myopia, and it may also have the ability to improve the accommodative function. There may be a slight myopic rebound after its cessation. The effect of long-term LRL therapy needs to be further explored.Trial registrationChinese Clinical Trial Registry: Chinese Clinical Trails registry: ChiCTR2100045250. Registered 9 April 2021; retrospectively registered. http://www.chictr.org.cn/showproj.aspx?proj=124250

Background Due to its high prevalence and associated sight-threatening pathologies, myopia has emerged as a major health issue in East Asia. The purpose was to test the impact on myopia development of a school-based intervention program aimed at increasing the time student spent outdoors. Methods A total of 3051 students of two primary (grades 1-5, aged 6-11) and two junior high schools (grades 7-8, aged 12-14) in both urban and rural Northeast China were enrolled. The intervention group (n = 1735) unlike the control group (n = 1316) was allowed two additional 20-min recess programs outside the classroom. A detailed questionnaire was administered to parents and children. Uncorrected visual acuity (UCVA) was measured using an E Standard Logarithm Vision Acuity Chart (GB11533-2011) at baseline, 6-month and 1-year intervals. A random subsample (n = 391) participated in the clinic visits and underwent cycloplegia at the beginning and after 1 year. Results The mean UCVA for the entire intervention group was significantly better than the entire control group after 1 year (P < 0.001). In the subgroup study, new onset of myopia and changes in refractive error towards myopia were direction during the study period was significantly lower in the intervention group than in the control group (3.70 % vs. 8.50 %, P = 0.048; -0.10 ± 0.65 D/year vs. -0.27 ± 0.52 D/year, P = 0.005). Changes in axial length and IOP were also significantly lower following the intervention group (0.16 ± 0.30 mm/year vs. 0.21 ± 0.21 mm/year, P = 0.034; -0.05 ± 2.78 mmHg/year vs. 0.67 ± 2.21 mmHg/year, P = 0.006). Conclusions Increasing outdoor activities prevented myopia onset and development, as well as axial growth and elevated IOP in children. Trial registration Current controlled trials NCT02271373 .

Purpose: Low-concentration atropine (LCA; 0.01%) is known to reduce the progression of myopia in axial myopes. The purpose of this study was to understand the role of LCA in premyopic children in preventing progression. Methods: A randomized case-control study of known premyopes was done between the use of LCA and no intervention. A total of 30 children were included in both groups. Results: The mean age in the LCA group was 7.7 ± 2.1 years (5-12 years), and in the control group, it was 7.2 ± 1.9 years (4-12 years). The mean baseline progression per year in the LCA group (before starting the eye drops) was − 0.72 ± 0.3 D, and in the control group, it was − 0.69 ± 0.4 D. At the end of the first year, the mean progression in the LCA group was − 0.31 ± 0.3 D versus − 0.76 ± 0.4 D, and the axial length increase was 0.12 ± 0.1 mm in the LCA group and 0.21 ± 0.2 mm in the control group. At the end of the second year, the mean progression compared with the baseline in the LCA group was − 0.6 ± 0.3 D versus − 1.75 ± 0.4 D, and the axial length showed an increase from baseline in the LCA group by 0.21 ± 0.2 mm, and in the control group, the increase was 0.48 ± 0.2 mm in 2 years. Conclusion: Low-concentration eye drops (0.01%) work in preventing the progression of axial myopia in premyopic children.

BackgroundTo assess prevalence and associated factors of changes in the ophthalmoscopic optic disc size and shape.MethodsThe case–control study included all highly myopic eyes (myopic refractive error ≤−6.0 diopters) and a randomly selected group of non-highly myopic eyes, examined in the population-based Beijing Eye Study 2001 and 2011.ResultsThe study included 89 highly myopic eyes (age:65.0±9.8 years) and 86 non-highly myopic eyes. Reduction in ophthalmoscopic disc size (prevalence, high myopia: 30 (33.7%) eyes; non-high myopia: 7 (8.1%) eyes) was associated with non-circular gamma zone enlargement (OR: 19.4; 95% CI: 6.7 to 56.6; p<0.001) and disc-fovea line elongation (OR: 2.80;95% CI: 1.12 to 6.98; p=0.03). Disc size reduction was correlated with a disc diameter shortening in direction of the widest gamma zone enlargement (correlation coefficient r=34; p=0.01). The perpendicular disc diameter remained mostly unchanged, resulting in an ovalisation of the ophthalmoscopic disc shape. Enlargement of the ophthalmoscopic disc size (prevalence, high myopia: 22 (24.7%) eyes; non-high myopia: 4 (4.7%) eyes) was associated with circular gamma zone enlargement (4.99; 95% CI: 1.95 to 12.8; p=0.001) and high myopia (OR: 4.29; 95% CI: 1.34 to 13.8; p=0.01).ConclusionsMyopic axial elongation may lead first to a Bruch’s membrane (BM) opening (BMO) shift into the foveal direction leading to BM overhanging into the nasal intrapapillary compartment, development and enlargement of gamma zone at the temporal disc side, reduction in the ophthalmoscopically visible disc area and ovalisation of the ophthalmoscopic disc shape. In a second step, an axial elongation-associated BMO enlargement may lead to a circular gamma zone increase and, due to the retraction of BM at the nasal disc border, to an enlargement of the ophthalmoscopically visible optic disc.

Purpose To investigate the additive effects of orthokeratology (OK) and atropine 0.01% ophthalmic solution, both of which are effective procedures to slow axial elongation in children with myopia. Study design Prospective randomized clinical trial. Methods Japanese children aged 8–12 years with a spherical equivalent refractive error of − 1.00 to − 6.00 diopters were included. A total of 41 participants who had been wearing the OK lenses successfully for 3 months were randomly allocated into two groups to receive either the combination of OK and atropine 0.01% ophthalmic solution (combination group) or monotherapy with OK (monotherapy group). Subjects in the combination group started to use atropine 0.01% ophthalmic solution once nightly from 3 months after the start of OK. Axial length was measured every 3 months using non-contact laser interferometry (IOLMaster), and the axial length measurement at month 3 of OK therapy was used as the baseline value in both groups. The increase in axial length over 1 year was compared between the two groups. Results A total of 40 consecutive subjects (20 subjects in the combination group and 20 in the monotherapy group) were followed for 1 year. The increase in axial length over 1 year was 0.09 ± 0.12 mm in the combination group and 0.19 ± 0.15 mm in the monotherapy group ( P  = 0.0356, unpaired t test). Conclusion During the 1-year follow-up, the combination of OK and atropine 0.01% ophthalmic solution was more effective in slowing axial elongation than OK monotherapy in children with myopia.

Purpose To investigate the relationship between relative corneal refractive power shift (RCRPS) and axial length growth (ALG) in bilateral myopic anisometropes treated with orthokeratology. Methods A total of 102 children with myopic anisometropia in this prospective interventional study were randomly assigned to the spectacle group and orthokeratology group. Axial length (AL) and corneal topography was measured at baseline and the 12-month follow-up visit. ALG was defined as the difference between the two measurements, and RCRPS profiles were calculated from two axial maps obtained. Results In the orthokeratology group, the ALG in the more myopic eye (0.06 ± 0.15 mm) was significantly smaller than that in the less myopic eye (0.15 ± 0.15 mm, p < 0.001), and the interocular difference in AL significantly decreased following 1-year treatment, from 0.47 ± 0.32 to 0.38 ± 0.28 mm ( p < 0.001). However, in the spectacle group, the ALG was similar between the two eyes, and the interocular difference in AL did not change significantly over one year (all p > 0.05). The interocular difference in ALG in the orthokeratology group was significantly correlated with the interocular difference in RCRPS (dRCRPS, β =−0.003, p < 0.001) and the interocular difference in baseline AL ( β =−0.1179, p < 0.001), with R 2 being 0.6197. Conclusion Orthokeratology was effective in decreasing the magnitude of anisometropia. The interocular variation in RCRPS is an important factor accounting for the reduction of interocular ALG difference in anisomyopic children post-orthokeratology. These results provide insight into establishing eye-specific myopia control guidelines during orthokeratology treatment for myopic anisometropes.

Background Transepithelial photorefractive keratectomy (Trans-PRK) is an effective and safe laser surgery for myopia. Following this procedure, a bandage contact lens is used to promote epithelial healing, reduce postoperative pain, and improve visual recovery. The base curve of these lenses may affect vision post-surgery, particularly in patients with steep corneas and high myopia. This study aims to investigate the impact of using bandage contact lenses with base curves of 8.4 mm versus 8.8 mm on visual recovery after Trans-PRK in patients with steep corneas and high myopia. Methods This is a randomized, double-blind, binocularly controlled, single-center trial. The study subjects are myopic patients scheduled for Trans-PRK. Both eyes in each patient will be treated consecutively with single-step Trans-PRK. After surgery, a contact lens with an 8.8-mm base curve will be placed on one eye, and a lens with an 8.4-mm base curve will be placed on the other. The primary objective is to determine the difference in early postoperative uncorrected visual acuity between the two eyes of patients with steep corneas and high myopia. Randomization will be conducted using a computer-generated random allocation sequence without blocks or restrictions. The sequence will be recorded in sealed opaque envelopes, maintained by the principal investigator until the trial’s conclusion. In this double-masked trial, subjects will not know which treatment each eye receives. Discussion This novel trial will provide information on how bandage contact lenses with different base curves promote epithelial healing and visual recovery after Trans-PRK, thus offering evidence for clinical practice. Trial registration ClinicalTrials.gov NCT06393855. Registered on May 1, 2024. https://clinicaltrials.gov/study/NCT06393855 .

Background Myopia is a prevailing refractive disorder and rapidly increases the risk of vision-threatening conditions. Earlier intervention is crucial to suppress myopia progression; however, the pharmacological and non-pharmacological therapies currently available have limitations. SAT-001 is a novel digital therapeutic software developed for myopia control and is designed to overcome the limitations of existing therapies. The present study aims to evaluate the efficacy and safety of the software as a medical device, SAT-001, for the inhibition of myopia progression and treatment in pediatric patients with myopia. Methods This clinical trial is a two-arm, prospective, randomized, open-label study with a duration of approximately 25 months, comprising a maximum of 52 weeks of participant participation. We will enroll 110 pediatric patients with myopia aged 5 to < 9 years, each with a spherical equivalent of − 0.75 D to − 5.75 D in each eye. Eligible participants will be randomly assigned in a 1:1 ratio to either the study group using SAT-001 with single-vision spectacles or the control group using single-vision spectacles alone. The change in the spherical equivalent refractive error (SER) at 48 weeks from baseline serves as the primary endpoint. The change in SER at 24 weeks and axial length at every 12 weeks from baseline will be the secondary endpoints. Each change will be assessed depending on the myopic severity. Treatment emergent adverse events will be evaluated for the safety analysis. Discussion This randomized controlled trial aims to confirm the efficacy and safety of SAT-001 in slowing pediatric myopia progression. The findings of this study could establish SAT-001 as an easily accessible, convenient, and non-invasive treatment option with minimal side effects, offering long-term myopia control from an early stage. Further research is needed to validate the effectiveness of SAT-001 for moderate to high myopia and concurrent conditions like astigmatism and to improve user engagement, diversify the program, and integrate with hospital-based treatments. Trial registration ClinicalTrials.gov: NCT06344572 ; date of registration: April 12, 2024 (retrospectively registered).

In recent years, with the rapid development of machine learning (ML), it has gained widespread attention from researchers in clinical practice. ML models appear to demonstrate promising accuracy in the diagnosis of complex diseases, as well as in predicting disease progression and prognosis. Some studies have applied it to ophthalmology, primarily for the diagnosis of pathologic myopia and high myopia-associated glaucoma, as well as for predicting the progression of high myopia. ML-based detection still requires evidence-based validation to prove its accuracy and feasibility. This study aims to discern the performance of ML methods in detecting high myopia and pathologic myopia in clinical practice, thereby providing evidence-based support for the future development and refinement of intelligent diagnostic or predictive tools. PubMed, Cochrane, Embase, and Web of Science were thoroughly retrieved up to September 3, 2023. The prediction model risk of bias assessment tool was leveraged to appraise the risk of bias in the eligible studies. The meta-analysis was implemented using a bivariate mixed-effects model. In the validation set, subgroup analyses were conducted based on the ML target events (diagnosis and prediction of high myopia and diagnosis of pathological myopia and high myopia-associated glaucoma) and modeling methods. This study ultimately included 45 studies, of which 32 were used for quantitative meta-analysis. The meta-analysis results unveiled that for the diagnosis of pathologic myopia, the summary receiver operating characteristic (SROC), sensitivity, and specificity of ML were 0.97 (95% CI 0.95-0.98), 0.91 (95% CI 0.89-0.92), and 0.95 (95% CI 0.94-0.97), respectively. Specifically, deep learning (DL) showed an SROC of 0.97 (95% CI 0.95-0.98), sensitivity of 0.92 (95% CI 0.90-0.93), and specificity of 0.96 (95% CI 0.95-0.97), while conventional ML (non-DL) showed an SROC of 0.86 (95% CI 0.75-0.92), sensitivity of 0.77 (95% CI 0.69-0.84), and specificity of 0.85 (95% CI 0.75-0.92). For the diagnosis and prediction of high myopia, the SROC, sensitivity, and specificity of ML were 0.98 (95% CI 0.96-0.99), 0.94 (95% CI 0.90-0.96), and 0.94 (95% CI 0.88-0.97), respectively. For the diagnosis of high myopia-associated glaucoma, the SROC, sensitivity, and specificity of ML were 0.96 (95% CI 0.94-0.97), 0.92 (95% CI 0.85-0.96), and 0.88 (95% CI 0.67-0.96), respectively. ML demonstrated highly promising accuracy in diagnosing high myopia and pathologic myopia. Moreover, based on the limited evidence available, we also found that ML appeared to have favorable accuracy in predicting the risk of developing high myopia in the future. DL can be used as a potential method for intelligent image processing and intelligent recognition, and intelligent examination tools can be developed in subsequent research to provide help for areas where medical resources are scarce. PROSPERO CRD42023470820; https://tinyurl.com/2xexp738.