A protocol for a single center, randomized, controlled trial assessing the effects of spectacles or orthokeratology on dry eye parameters in children and adolescents.

Background: The prevalence of myopia among adolescents is increasing precipitously in China, and the popularity of orthokeratology (OK) lenses as an effective treatment for controlling myopia progression is rising. This protocol assessed and compared the clinical dry eye parameters in children and adolescents with myopia treated with spectacles or OK lenses. Methods and analysis: This single-masked randomized control trial will include 300 participants (aged 8-17 years) with myopia treated with OK lens (study group) or spectacles (control group). We will record the ocular surface disease index, visual analog scale score, noninvasive tear breakup time, tear meniscus height, meibomian gland score, ocular redness score, visual acuity, tear Matrix Metalloproteinase-9 concentration, tear Lymphotoxin alpha levels at baseline, and after 1-, 3-, 6-, and 12-month. Discussion: This study will be a standardized, scientific, clinical trial designed to evaluate the dry eye parameters in children and adolescents with myopia treated with OK lenses for myopia control. Ethics and dissemination: This study has been approved by the Ethics Committee of He Eye Specialist Hospital [ethics approval number: IRB(2023)K024.01]. Before participating in the trial, written informed consent will be obtained from all patient's parents or guardians. The findings of this study will be showcased at both local and international conferences and will also be submitted for publication in reputable peer-reviewed journals. Trial registration number: Clinicaltrials.gov: NCT06023108 {2a, 2b}.

Efficacy of orthokeratology lens with the modified small treatment zone on myopia progression and visual quality: a randomized clinical trial.

BACKGROUND: To evaluate the long-term effectiveness of orthokeratology (ortho-K) lenses with small treatment zone (STZ) or conventional treatment zone (CTZ) in controlling axial elongation in children with myopia as well as the impact on visual quality. We also sought to determine the effect of retinal visual signal quality on axial elongation. METHODS: This is a prospective randomized controlled study. A total of 140 participants (age ranging from 8 to 12 years) were randomly assigned to wear either STZ or CTZ ortho-K lenses. STZ ortho-K lenses design was achieved by changing the depth of reverse zone and the sagitta height of the optical zone. Using the IOL-Master 500, axial length (AL) was measured at baseline and after 6, 12 and 18 months of ortho-K treatment. Spherical aberration (SA) and corneal topographic parameters were obtained by the Pentacam anterior segment analyzer at baseline and the 1-month follow-up visit, and optical qualities were assessed by optical quality analysis system-II (OQAS-II) at baseline and after 1 month of lens wearing. Optical quality parameters mainly included the modulation transfer function (MTF) cutoff, Strehl ratio (SR), objective scattering index (OSI), and predicted visual acuity (PVA). RESULTS: A total of 131 participants completed the study, including 68 in the STZ group and 63 in the CTZ group. The STZ group had significantly reduced AL elongation compared to the CTZ group after treatment (12 months: 0.07 ± 0.11 mm vs. 0.14 ± 0.12 mm, P = 0.002; 18 months: 0.17 ± 0.15 mm vs. 0.26 ± 0.16 mm, P = 0.002). The topography in the STZ group showed a smaller treatment zone (TZ) diameter (2.50 ± 0.23 mm vs. 2.77 ± 0.18 mm, P < 0.001), a wider defocus ring width (2.45 ± 0.28 mm vs. 2.30 ± 0.30 mm, P = 0.006), and larger values of total amount of defocus (119.38 ± 63.71 D·mm2 vs. 91.40 ± 40.83 D·mm2, P = 0.003) and total SA (0.37 ± 0.25 µm vs. 0.25 ± 0.29 µm, P = 0.015), compared with the CTZ group. Objective visual quality decreased in both groups (P < 0.001). This was evidenced by a greater decrease in MTF cutoff (- 14.24 ± 10.48 vs. - 10.74 ± 9.46, P = 0.047) and SR values (- 0.09 ± 0.07 vs. - 0.06 ± 0.07, P = 0.026), and an increase in OSI value (0.84 ± 0.72 vs. 0.58 ± 0.53, P = 0.019). PVA9% decreased significantly in the STZ group but not the CTZ group. A statistically significant negative correlation was found between the changes in total SA and MTF cutoff values (r = - 0.202, P = 0.025). AL changes were associated with sex, change of MTF cutoff value, increment of total SA and TZ area. CONCLUSIONS: Compared with CTZ ortho-K lenses, STZ ortho-K lenses significantly inhibited axial elongation in children with myopia while moderately reducing their objective visual quality. Axial elongation was affected by retinal visual quality, and it may be a possible mechanism for ortho-K slowing myopia progression. Trial registration This trial is registered at Chinese Clinical Trial Registry on November 5, 2019 with trial registration number: ChiCTR1900027218. https://www.chictr.org.cn/showproj.html?proj=45380.

Clinical Features and Visual Outcome of Infectious Keratitis Associated with Orthokeratology Lens in Korean Pediatric Patients.

Purpose: To investigate the clinical features and visual outcome of infectious keratitis associated with Orthokeratology (Ortho-K) lens in Korean pediatric patients. Methods: We retrospectively reviewed medical records of patients diagnosed with Ortho-K lens-associated infectious keratitis from June 2005 to April 2020 at a tertiary referral hospital. Patients' demographics, clinical features, microbiological evaluation, and treatment methods were assessed and factors related to final visual outcomes were analyzed. Results: The study included 26 eyes of 26 patients (19 female, 7 male; mean age: 11.9 years), with an average Ortho-K lens wear duration of 33.7 ± 21.2 months. The highest number of cases occurred in summer (42.3%, 11/26). Central or paracentral corneal lesions were observed in 96.2% (25/26) of cases, with a mean corneal epithelial defect size of 5.13 mm². Pseudomonas aeruginosa was the most commonly isolated organism (n = 5), followed by Serratia marcescens (n = 4). All patients responded to medical treatment without needing surgical intervention. 72% of cases achieved favorable visual outcomes (Snellen BCVA > 6/12), while 8% experienced severe visual impairment (Snellen BCVA ≤ 6/60) due to residual central corneal opacities. Multivariable analysis showed that non-summer seasons, duration from symptom onset to presentation, and corneal epithelial defect size were significantly associated with final logMAR BCVA (p = 0.043, p = 0.040, and p = 0.002, respectively). Failed autorefraction at presentation due to an Ortho-K-related infectious keratitis lesion was a significant predictor of poor final visual outcome (Snellen BCVA ≤ 6/12) (OR = 38.995, p = 0.030). Conclusions: Ortho-K lens-related infectious keratitis can lead to permanent corneal opacities and potentially devastating visual outcomes in children. Delayed time to presentation, large corneal lesions, failure of autorefraction, and non-summer seasons were associated with poorer outcomes. Proper education and early detection would be key to safe use of orthokeratology lenses in pediatric patients.

Long-term effect of orthokeratology on controlling myopia progression in children with allergic conjunctivitis.

BACKGROUND: To observe whether the effect of orthokeratology (OK) lenses on myopia control in children with allergic conjunctivitis (AC) after three years of wear differs from that in children without allergic conjunctivitis (nAC) and to identify the potential influencing factors. METHODS: This was a retrospective case-control study. Patients aged 8-15 years who were fitted with OK lenses in 2019 were collected. A three-year follow-up was also conducted, documenting all corneal adverse events (AEs) and the increase in axial length (AL) of the eye after three years of wearing OK lenses. Patients were divided into groups with and without AC based on their medical history and physical signs at the initial fitting. Baseline data and AL elongation after three years were compared between the two groups. RESULTS: A total of 309 patients were included in this study, with 47 in the AC group and 262 in the nAC group. There were no statistically significant differences between the two groups in terms of age, sex, spherical equivalent (SE), AL of the eye and environment. After three years of OK lens wear, the AL elongation in the AC group was 0.96 ± 0.45 mm, whereas it was 0.69 ± 0.45 mm in the nAC group (P < 0.001). The extent of AL elongation in AC patients was significantly greater than that in nAC patients. During the three-year follow-up period, the duration of OK lenses discontinuation due to corneal AEs in the AC group was greater than that in the nAC group (P < 0.05). CONCLUSIONS: This study found that allergic conjunctivitis can affect the efficacy of OK lenses in controlling myopia after three years of treatment.

Effects of orthokeratology on corneal reshaping and the delaying of axial eye growth in children.

Purpose: To investigate the inhibition of myopia progression and axial elongation in children wearing orthokeratology (OK) lenses, as well as to evaluate the status of corneal reshaping, this study explores the relationship between changes in central corneal curvature (K-value) and e-value induced by OK lenses and axial elongation. Methods: In this study, it is planned to select children aged 8-15 who wear orthokeratology lenses at the Pediatric Ophthalmology and Strabismus Clinic of the Second Affiliated Hospital of Dalian Medical University. All children will undergo slit lamp examination, visual acuity assessment, computerized refraction, intraocular pressure measurement, biometry, and corneal topography examination before lens wear and at 1 month, 3 months, and 6 months after lens wear in the pediatric ophthalmology clinic. Based on age (lower age group (8 < age ≤12 years); higher age group (12 < age ≤15 years)) and baseline equivalent spherical (SE) value (mild myopia group (-1.00 D < SE ≤ -3.25D); moderate myopia group (-3.25 D < SE ≤ -6.00 D)), four groups will be formed by pairing these factors. Suitable data will be selected according to inclusion and exclusion criteria, and different groups will be included. Data will be organized, and statistical analysis will be performed using SPSS software to obtain the results. The expected results will be discussed and analyzed. Results: After wearing OK lenses, all four groups achieved good visual acuity at follow-up. At 6 months, there were no significant differences in visual acuity among the four groups (P = 0.149, >0.05). There were no significant differences in refractive error among the four groups (P = 0.066, >0.05). Baseline axial length differed significantly among the four groups (P = 0.000, <0.001), with the LM group having longer axial length than the LL group (P < 0.001, paired samples t-test), and the HM group having longer axial length than the HL group (P < 0.001, paired samples t-test). However, there were no significant differences in axial length change compared to baseline among the groups at 1 month, 3 months, and 6 months (P 1 = 0.053; P 3 = 0.557; P 6 = 0.329, >0.05). Significant differences were observed in corneal flat K-value change compared to baseline among the four groups at 1 month, 3 months, and 6 months (P 1 = 0.001, P 3 = 0.001, P 6 = 0.004, <0.05). There were no significant differences in e-value change among the groups at 1 and 3 months (P 1 = 0.205, P 3 = 0.252, >0.05), but significant differences were found in e-value change compared to baseline at 6 months (P 6 = 0.010, <0.05). Multiple regression analysis with changes in central corneal flat K-value and e-value as independent variables and axial elongation as the dependent variable showed a correlation between e-value change at 6 months and axial elongation (P = 0.004, <0.05), indicating a negative correlation. Conclusion: Orthokeratology (OK) lenses effectively improve myopic children's vision by reshaping the cornea, leading to reduced central corneal curvature and flattening of its anterior surface. The effectiveness of OK lenses is not significantly affected by age or initial myopia severity. Children of varying ages and myopia levels experience similar levels of axial length control with OK lens wear. Changes in corneal shape due to OK lenses affect axial elongation, with greater changes in corneal morphology associated with smaller increases in axial length.

Impact of the coronavirus disease 2019 pandemic on the progression, prevalence, and incidence of myopia: A systematic review.

We systematically reviewed the literature on the effects of the coronavirus disease 2019 (COVID-19) pandemic on the progression, prevalence, and incidence of myopia. A comprehensive literature search was performed on PubMed, Cochrane Central Register of Controlled Trials, and Scopus databases. Studies included in the review assessed myopia progression, prevalence, and/or incidence as the primary outcome. Of 523 articles yielded in the initial search, 23 studies (6 cross-sectional and 17 cohort) were eligible for inclusion. Sixteen of these were conducted in China and one each in Hong Kong, Turkey, Spain, Israel, India, Korea, and Tibet. Quality appraisals were conducted with the Joanna Briggs Institute Critical Appraisal Checklists. Of the included studies, a large majority reported a greater myopic shift and increase in myopia prevalence during the COVID-19 pandemic compared to the pre-COVID-19 years. All three studies on myopia incidence showed increased incidence during the COVID-19 pandemic. Myopia progression accelerated during the COVID-19 pandemic, even in individuals using low-concentration atropine eye drops in two studies but not in those using orthokeratology treatment in one study. Overall, the studies found that the COVID-19 pandemic and its associated home confinement measures generally increased myopia progression, prevalence, and incidence, even in individuals using low-concentration atropine eye drops.

Add-on effect of using 0.05% atropine in fast progressors of orthokeratology: A preliminary retrospective study.

PURPOSE: To investigate the potential benefit of combining orthokeratology (OK) lenses with 0.05% atropine ophthalmic solution on the efficacy of myopia control in the fast progressors of OK. METHODS: Average axial length (AL) elongation of both eyes in 70 participants using OK lenses alone or OK lenses combined with 0.05 % atropine ophthalmic solution was retrospectively reviewed. During the observation period (phase 1), all participants exhibited an AL elongation that exceeded 0.15 mm over a 6-month period or 0.3 mm over a 12-month period. Subsequently, the participants were divided into two groups: one group received nightly 0.05 % atropine ophthalmic solution in addition to OK lenses for another 1 year (OKA), while the other group continued using OK lenses alone (phase 2). The changes in AL elongation over time and the differences in AL elongation between the two groups were then compared. RESULTS: The baseline and phase 1 demographics and characteristics of the participants was similar between the two groups (all p > 0.05). when considering a one-year timeframe, the OKA group displayed a significantly less AL elongation compared to the OK group (0.14 ± 0.13 mm vs 0.27 ± 0.12 mm, p < 0.001). Within the OKA group, the AL elongation in the second half of the year was significantly faster than in the first half (0.12 ± 0.11 mm vs 0.02 ± 0.14 mm, p = 0.01). Conversely, there was no significant difference in AL elongation between the OK group in the first and second half of the year (0.12 ± 0.07 mm vs 0.15 ± 0.08 mm, p = 0.71). The combination of 0.05 % atropine ophthalmic solution had a significant effect on 1-year AL elongation (p < 0.001). CONCLUSIONS: This study provided preliminary evidence that the combination of OK lenses and 0.05% atropine ophthalmic solution can significantly enhance the effectiveness of myopia control.

Development and evaluation of a deep neural network model for orthokeratology lens fitting.

PURPOSE: To optimise the precision and efficacy of orthokeratology, this investigation evaluated a deep neural network (DNN) model for lens fitting. The objective was to refine the standardisation of fitting procedures and curtail subjective evaluations, thereby augmenting patient safety in the context of increasing global myopia. METHODS: A retrospective study of successful orthokeratology treatment was conducted on 266 patients, with 449 eyes being analysed. A DNN model with an 80%-20% training-validation split predicted lens parameters (curvature, power and diameter) using corneal topography and refractive indices. The model featured two hidden layers for precision. RESULTS: The DNN model achieved mean absolute errors of 0.21 D for alignment curvature (AC), 0.19 D for target power (TP) and 0.02 mm for lens diameter (LD), with R2 values of 0.97, 0.95 and 0.91, respectively. Accuracy decreased for myopia of less than 1.00 D, astigmatism exceeding 2.00 D and corneal curvatures >45.00 D. Approximately, 2% of cases with unique physiological characteristics showed notable prediction variances. CONCLUSION: While exhibiting high accuracy, the DNN model's limitations in specifying myopia, cylinder power and corneal curvature cases highlight the need for algorithmic refinement and clinical validation in orthokeratology practice.

Anisomyopia and orthokeratology for myopia control - Axial elongation and relative peripheral refraction.

PURPOSE: To investigate axial elongation (AE) and changes in relative peripheral refraction (RPR) in anisomyopic children undergoing orthokeratology (ortho-k). METHODS: Bilateral anisomyopic children, 7-12 years of age, were treated with ortho-k. Axial length (AL) and RPR, from 30° nasal (N30°) to 30° temporal (T30°), were measured at baseline and every 6 months over the study period. AE, changes in RPR and changes in the interocular AL difference were determined over time. RESULTS: Twenty-six of the 33 subjects completed the 2-year study. The AE of the higher myopic (HM) eyes (at least 1.50 D more myopia than the other eye) (0.26 ± 0.29 mm) was significantly smaller than for the less myopic (LM) eyes (0.50 ± 0.27 mm; p = 0.003), leading to a reduction in the interocular difference in AL (p = 0.001). Baseline RPR measurements in the HM eyes were relatively more hyperopic at T30°, N20° and N30° (p ≤ 0.02) and greater myopic shifts were observed at T20° (p < 0.001), T30° (p < 0.001), N20° (p = 0.02) and N30° (p = 0.01) after lens wear. After 2 years of ortho-k lens wear, temporal-nasal asymmetry increased significantly, being more myopic at the temporal locations in both eyes (p < 0.001), while AE was associated with the change in RPR at N20° (ß = 0.134, p = 0.01). The interocular difference in AE was also positively associated with the interocular difference in RPR change at N30° (ß = 0.111, p = 0.02). CONCLUSIONS: Ortho-k slowed AE in bilateral anisomyopia, with slower growth in the HM eyes leading to a reduction in interocular AL differences. After ortho-k, RPR changed from hyperopia to myopia, with greater changes induced in the HM eyes, and slower AE was associated with a more myopic shift in RPR, especially in the nasal field of both eyes.

Benefits and risks of orthokeratology treatment: a systematic review and meta-analysis.

BACKGROUND: This meta-analysis reviews the evidence for the risks and benefits associated with orthokeratology (OK) treatment compared with other methods of myopia control in children and adults. METHODS: A systematic search of Cochrane Central Register of Controlled Trials, Pubmed, Embase and Ovid was conducted from database inception to 22nd August 2021. Studies that reported on risks, visual and ocular biometric effects of OK in patients > 5 years of age with myopia (- 0.75 to - 6.00D) were included. Main outcomes are change in axial length and any adverse event. RESULTS: Fourty-five papers were included in this systematic review and meta-analysis. The quality of data was variable and of moderate certainty, and selection bias likely skewed the results towards a relative benefit for OK. The rate of axial elongation in children was lower for OK treatment compared to other treatment modalities at one year (MD - 0.16 mm, 95% CI - 0.25 to - 0.07). Rate of change in axial length in children rebounded after OK discontinuation compared to participants who continued treatment (MD 0.10 mm, 95% CI 0.06 to 0.14). Adults and children wearing OK were up to 3.79 times more likely to experience an adverse event when compared with conventional contact lenses (OR 3.79, 95% CI 1.24 to ll.), though this evidence base is underdeveloped and requires additional well-designed studies for substantial conclusions to be drawn. CONCLUSIONS: OK arrests myopia progression while in use, however, there remain unanswered questions about the optimal duration of treatment, discontinuation effects and long-term risk for adverse events.

Can Google Help Your Nearsightedness? A Google Trend Analysis of Public Interest in Myopic Progression.

Purpose: To explore public interest in myopia progression and management and to correlate these trends to available treatments. Methods: Keywords were chosen for interest in myopia overall and those signifying interest in myopia treatments. Treatment options were separated into four main categories: atropine, glasses, contact lenses, and orthokeratology. Search terms were queried across ten years of Google Trends data and the relative search volume was analyzed to quantify the change in search volume over time. Results: A positive linear trend over time was present for all myopia interest keywords except "nearsighted" (p = 0.074) and "near work myopia" (p = 0.086). Interest in the four myopia treatment categories included in this study also displayed a significant positive trend over time. There is also a statistically significant positive correlation between all four treatment options and four of the seven categories of population interest, "myopia control", "myopia", "myopia progression", and "screen time myopia". Conclusion: This study demonstrates the utility of GT to correlate public interest in myopia treatments over time. All treatment terms had statistically significant linear search volume growth over a ten-year period. The positive correlation between interest in myopia as a health problem and available treatments supports existing evidence that GT can track rising public health concerns and corresponding treatment-seeking behaviors.

International trends in rigid contact lens prescribing (2000-2023): An update.

PURPOSE: Rigid contact lenses have an important role in contact lens practice. The purpose of this work is to update earlier surveys by describing global trends in rigid lens fitting between 2000-2023. METHOD: An annual contact lens prescribing survey was sent to eye care practitioners in up to 71 countries between 2000 and 2023. Data relating to 342,500 fits undertaken in 20 countries returning reliable longitudinal data were analysed in respect of rigid lens fitting, defined as the fitting of any design of a contact lens manufactured in a rigid material. RESULTS: Overall, rigid lens prescribing increased slightly over time, from 14.2 % of lens fits in 2000 to 15.2 % in 2023 (p < 0.0001). However, post-hoc analysis shows that the change over time is best described as a decline between 2000 and 2012, followed by a steady increase subsequently. There were significant differences in rigid lens prescribing between countries (p < 0.0001). The difference between the percentage of males fitted with rigid lenses, as a proportion of all contact lenses (12.7 %), and females (12.0 %) is significant (p < 0.0001), although not clinically meaningful. Rigid lens wearers are older at fitting than soft lens wearers (38.7 vs 31.3 years, respectively) (p < 0.0001). Analysis of 5,994 rigid lens fits prescribed currently (2019-2023) were categorised as: corneal sphere - 30 %; scleral and corneo-scleral - 28 %; corneal myopia control/orthokeratology - 21 %; and corneal complex (including toric, multifocal and monovision) - 16 %. CONCLUSION: There has been a slight increase in rigid lens fitting during the second decade of this century. This increase is apparently due to a 'repurposing' of rigid lenses, with the growth of scleral/corneo-scleral and myopia control/orthokeratology lens fits essentially replacing conventional spherical corneal lens fits.

The efficacy of orthokeratology lenses with smaller back optic zone diameter in myopia control. A meta-analysis.

PURPOSE: This study was conducted to determine whether orthokeratology (OK) lenses with a smaller back optic zone diameter (BOZD) could exhibit stronger myopia control effects. METHOD: A meta-analysis was registered in PROSPERO (CRD42023408184). A comprehensive systematic database search was conducted, encompassing PubMed, Cochrane Library, EMBASE, MEDLINE, Web of Science, Ovid, CNKI and CBM, to identify relevant studies up to 25 March 2023. The primary inclusion criteria for this meta-analysis were studies that investigated the myopia control effect of OK lenses with a small optical treatment area (≤5 mm). To assess the quality of the retrieved articles, two researchers evaluated them using the Cochrane bias risk assessment criteria. The primary outcome measures were the changes in axial length (AL) and refractive error, using the weighted mean differences (WMD) and 95% confidence intervals (CI) to assess differences between small and traditional back optical treatment zone groups in terms of these outcomes. RESULTS: The analysis encompassed five eligible studies, with a 1 year duration. The average difference in AL between the groups was 0.12 mm (WMD = -0.12, 95% CI [-0.16, -0.09], p < 0.00001). Likewise, the average difference in refractive error between the two groups was 0.44 D (WMD = 0.44, 95% CI [0.30, 0.57], p < 0.00001). None of the studies reported severe adverse events. CONCLUSIONS: Current evidence suggests that OK lenses with smaller back optical treatment zone are more effective in preventing myopia progression than traditional lenses. However, a longer-term evaluation is warranted.

BCLA CLEAR Presbyopia: Management with corneal techniques.

Corneal techniques for enhancing near and intermediate vision to correct presbyopia include surgical and contact lens treatment modalities. Broad approaches used independently or in combination include correcting one eye for distant and the other for near or intermediate vision, (termed monovision or mini-monovision depending on the degree of anisometropia) and/or extending the eye's depth of focus [1]. This report reviews the evidence for the treatment profile, safety, and efficacy of the current range of corneal techniques for managing presbyopia. The visual needs and expectations of the patient, their ocular characteristics, and prior history of surgery are critical considerations for patient selection and preoperative evaluation. Contraindications to refractive surgery include unstable refraction, corneal abnormalities, inadequate corneal thickness for the proposed ablation depth, ocular and systemic co-morbidities, uncontrolled mental health issues and unrealistic patient expectations. Laser refractive options for monovision include surface/stromal ablation techniques and keratorefractive lenticule extraction. Alteration of spherical aberration and multifocal ablation profiles are the primary means for increasing ocular depth of focus, using surface and non-surface laser refractive techniques. Corneal inlays use either small aperture optics to increase depth of field or modify the anterior corneal curvature to induce corneal multifocality. In presbyopia correction by conductive keratoplasty, radiofrequency energy is applied to the mid-peripheral corneal stroma, leading to mid-peripheral corneal shrinkage and central corneal steepening. Hyperopic orthokeratology lens fitting can induce spherical aberration and correct some level of presbyopia. Postoperative management, and consideration of potential complications, varies according to technique applied and the time to restore corneal stability, but a minimum of 3 months of follow-up is recommended after corneal refractive procedures. Ongoing follow-up is important in orthokeratology and longer-term follow-up may be required in the event of late complications following corneal inlay surgery.

Optical coherence tomography angiography reveals macular microvascular changes in myopic adolescents following orthokeratology lens wear.

BACKGROUND: This study aimed to investigate the 6-month effects of wearing orthokeratology (OK) lenses on the retina vessel density (VD), vessel diameter index (VDI), and foveal avascular zone (FAZ) of myopia children using optical coherence tomography angiography, and to further investigate the underlying mechanisms of Orthokeratology in myopia control. METHODS: Sixty-two eyes form 62 subjects were included in the study. Baseline and 6-month measurements of axial length (AL), anterior chamber depth (ACD), FAZ area, FAZ perimeter, FAZ circularity, vessel density (VD) and VDI from both the superficial capillary plexus (SCP) and deep capillary plexus (DCP) were obtained. RESULTS: The mean age of the participants was 11.02 years (range: 8 years to 15 years), with 41.9% males and 58.1% females. Six months after orthokeratology, ACD decreased significantly, and AL remain unchanged. SCP-VD and DCP-VD significantly increased after treatment without obvious change of VDI, and FAZ parameters remained unchanged. During follow-up period, SCP-VD increased in all subgroups especially in mild myopia group, and DCP-VD increased significantly in all subgroups except for the group 8-10 years. CONCLUSION: After the 6-month treatment of orthokeratology in myopia children, the macular microvasculature changed significantly. We observed a significant increase of vessel densities in both SCP and DCP without obvious effect on vascular morphology. The changes of DCP-VD tended to be more sensitive in the elder subgroup, and the efficacy of orthokeratology might be greater in mild myopia group. OCT-A may provide additional information on myopia progression and the mechanisms of controlling myopia with OK lens treatment.

Development and psychometric evaluation of beliefs about the orthokeratology lens compliance scale (BOLCS): Based on the theory of planned behavior.

PURPOSE: Non-adherence to standard wear, care, and follow-up procedures is a major risk factor for contact lens-related complications. The effectiveness of orthokeratology largely depends on the wearer's adherence. However, a deficiency in scales capturing adherence beliefs pertinent to orthokeratology exacerbates the lack of guidance for effective intervention strategies. The purpose of this study is to develop and evaluate the psychometric properties of a new scale based on the Theory of Planned Behavior that assesses the level of adherence among ortho-k wearers. METHODS: This study involved three stages following the STROBE checklist: (1) developing initial scale items based on the Theory of Planned Behavior, a literature review, and a qualitative study; (2) evaluation of content and face validity; (3) psychometric testing on 296 participants. Item analysis, based on Classical Test Theory, assessed the overall consistency, reliability, and validity of the scale. RESULTS: The final 37-item Beliefs about the Orthokeratology Lens Compliance Scale (BOLCS) comprises 11 dimensions. The Cronbach's alpha coefficients for each dimension ranged from 0.560 to 0.798. The folded half reliabilities were 0.845, and the combined reliabilities ranged from 0.676 to 0.793, indicating strong reliability. Item-level CVI (I-CVI) and scale-level CVI/average (S-CVI/Ave) values, assessed by the panel, ranged from 0.71 to 1 and 0.954, respectively. Exploratory and confirmatory factor analyses supported a factor structure consistent with the theoretical model. CONCLUSIONS: The scale's construction adhered to a standardized process, yielding preliminary validation results with satisfactory reliability and validity.

Comparison of myopic control between orthokeratology contact lenses and defocus incorporated multiple segments spectacle lenses.

Purpose: The purpose of this study was to compare the differences in myopic control effects between orthokeratology (OK) contact lenses and defocus incorporated multiple segments (DIMS) spectacle lenses. Methods: A retrospective cohort study was conducted that included patients who had received OK lens, DIMS spectacle lens or single-vision spectacle treatments. A total of 54 eyes from 27 individuals, 38 eyes from 19 individuals and 42 eyes from 21 individuals were enrolled into the OK lens, DIMS and control groups, respectively. The primary outcomes were the changes in the spherical equivalent refraction (SER) and axial length (AXL) among the groups. A repeated-measure ANCOVA was adopted to calculate the SER progression and AXL elongation of the OK lens group compared with the DIMS group. Results: The difference in the SER progression was clinically non-significant in the OK lens group compared with the DIMS and control groups (P = 0.001). The total AXL elongation results were similar between the OK lens and DIMS groups, but these were lower than in the control group (P = 0.005). The repeated-measure ANCOVA revealed that the SER progression difference during the study interval was clinically non-significant in the OK lens group when compared with the DIMS group (P = 0.028). The AXL elongation results between the OK lens and DIMS populations did not illustrate a significant difference (P = 0.607). In a subgroup analysis of moderate astigmatism, better AXL control was observed in the DIMS subgroup compared with the OK lens subgroup (P = 0.016). Conclusions: The OK lens demonstrated a clinically non-significant effect on the SER and AXL controls compared with the DIMS spectacle lens.

Myopia Control Effect of Repeated Low-Level Red-Light Therapy Combined with Orthokeratology: A Multicenter Randomized Controlled Trial.

PURPOSE: To investigate the efficacy and safety of repeated low-level red-light (RLRL) therapy combined with orthokeratology among children who, despite undergoing orthokeratology, exhibited an axial elongation of at least 0.50 mm over 1 year. DESIGN: Multicenter, randomized, parallel-group, single-blind clinical trial (ClinicaTrials.gov identifier, NCT04722874). PARTICIPANTS: Eligible children were 8-13 years of age with a cycloplegic spherical equivalent refraction of -1.00 to -5.00 diopters at the initial orthokeratology fitting examination and had annual axial length (AL) elongation of ≥0.50 mm despite undergoing orthokeratology. Forty-eight children were enrolled from March 2021 through January 2022, and the final follow-up was completed in March 2023. METHODS: Children were assigned randomly to the RLRL therapy combined with orthokeratology (RCO) group or to the orthokeratology group in a 2:1 ratio. The orthokeratology group wore orthokeratology lenses for at least 8 hours per night, whereas the RCO group received daily RLRL therapy twice daily for 3 minutes in addition to orthokeratology. MAIN OUTCOME MEASURES: The primary outcome was AL change measured at 12 months relative to baseline. The primary analysis was conducted in children who received the assigned intervention and completed at least 1 follow-up after randomization using the modified intention-to-treat principle. RESULTS: Forty-seven children (97.9%) were included in the analysis (30 in the RCO group and 17 in the orthokeratology group). The mean axial elongation rate before the trial was 0.60 mm/year and 0.61 mm/year in the RCO and orthokeratology groups, respectively. After 12 months, the adjusted mean AL changes were -0.02 mm (95% confidence interval [CI], -0.08 to +0.03 mm) in the RCO group and 0.27 mm (95% CI, 0.19-0.34 mm) in the orthokeratology group. The adjusted mean difference in AL change was -0.29 mm (95% CI, -0.44 to -0.14 mm) between the groups. The percentage of children achieving an uncorrected visual acuity of more than 20/25 was similar in the RCO (64.3%) and orthokeratology (65.5%) groups (P = 0.937). CONCLUSIONS: Combining RLRL therapy with orthokeratology may offer a promising approach to optimize axial elongation control among children with myopia. This approach also potentially allows children to achieve satisfactory visual acuity, reducing daytime dependence on corrective eyewear. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Bilateral axial length growth patterns of myopic anisometropes undergoing sequential monocular to binocular orthokeratology treatment.

PURPOSE: To investigate bilateral axial length (AL) growth patterns and interactions of myopic eyes in anisometropic children during unilateral orthokeratology (OK) treatment in their singularly myopic eyes (Eyes1), followed by bilateral treatment when their second eyes (Eyes2) developed myopia. METHODS: This study enrolled 94 eyes from 47 anisometropes (20 males). All patients had undergone monocular OK treatment for > 1 year followed by binocular treatment for > 1 year. Axial growth of Eyes1 and Eyes2 during the first year of monocular treatment (Stage 1), average annual axial elongation during the monocular treatment period, and axial elongation during the first year of binocular treatment (Stage 2) were respectively termed: S1E1 and S1E2, Annual E1 and Annual E2, and S2E1 and S2E2. Associations between AL growth and age, sex, interval time, and ocular parameters were analysed using correlation and generalised estimating equation (GEE) analysis. RESULTS: During the monocular period, Eyes1 showed less AL growth (S1E1: 0.05 ± 0.18 mm; Annual E1: 0.05 ± 0.21 mm) than Eyes2 (S1E2: 0.51 ± 0.24 mm; Annual E2: 0.52 ± 0.25 mm) (all p < 0.001). During the binocular period, there was no significant difference between S2E1 and S2E2(0.21 ± 0.14 mm v. 0.19 ± 0.17 mm, p = 0.951). Between monocular and binocular periods, Eyes1 had significantly higher S2E1 compared to S1E1 and Annual E1 (both p < 0.001), and Eyes2 had significantly lower S2E2 than S1E2 and Annual E2 (both p < 0.001). In the GEE model, spherical equivalent refraction (SER) and between periods interval time showed independently significant associations with AL growth after adjusting for age and sex. CONCLUSION: Orthokeratology can significantly control AL growth in unilateral myopia. AL growth of the initial myopic OK-treated eyes accelerated relative to the monocular period when contralateral eyes developed myopia and assumed OK treatment. During the binocular treatment phase, OK lenses showed moderate and comparable effects on AL retardation across both eyes.