Fitting of Orthokeratology in the United States: A Survey of the Current State of Orthokeratology.

SIGNIFICANCE: The Fitting of Orthokeratology in the United States (FOKUS) survey provides information about the US orthokeratology market. This independent survey is the first to attain detailed assessment of the orthokeratology market. PURPOSE: This study aimed to develop and administer a survey to eye care providers in the United States who are managing orthokeratology patients and those who are not, to determine a profile of prescribers, patients, and overall market. METHODS: The FOKUS survey was administered and distributed online. Outcome measures of the FOKUS survey involved general categories of (1) practice and practitioner profiles, (2) clinical prescribing patterns, (3) patient profile, (4) products and marketing, (5) fees, and (6) market size and growth. RESULTS: The number of eye care providers who are actively fitting and managing orthokeratology patients in the United States is approximately 3000. A total of 545 responded to the survey; 283 reported that they were actively fitting orthokeratology. Furthermore, 68% of respondents prescribed orthokeratology with the intent of managing myopia, 53% monitor axial length, and 61% start orthokeratology patients at 13 years or younger. The mean number of years a patient wears orthokeratology is 7.8 years. A commonly reported complication with orthokeratology is corneal staining. Microbial keratitis is rarely or never seen by 86% of respondents. Of those currently fitting, 56% anticipate growth of orthokeratology fitting over the next 12 months. Of those not currently fitting orthokeratology, 46% plan to start within 2 years. CONCLUSIONS: Orthokeratology represents a small but growing segment of the US contact lens market. The number of practitioners actively prescribing and fitting orthokeratology in the United States is approximately 3000 with high potential for growth within the next 2 years. Results of the FOKUS survey are relevant to practitioners currently fitting or considering orthokeratology, manufacturers, educators, and researchers as baseline for future orthokeratology market assessment.

The Role of Orthokeratology in Myopia Management.

ABSTRACT: Intervention to slow axial elongation and progressing degree of myopia has become an important public health issue. Although orthokeratology (OrthoK) has been prescribed to temporarily reduce or eliminate refractive error, myopic children undergoing OrthoK have shown significant slowing of axial elongation and myopic progression. This review presents data on the efficacy, benefits, and risks of the use of OrthoK to slow axial elongation in myopic children. It also discusses how OrthoK fits into an overall strategy of myopia management in practice compared with alternative prescribed interventions to slow myopic progression. Other factors discussed are patient candidacy, impact on vision-related quality of life, and use of OrthoK in combination with pharmaceutical agents. With precise fitting, careful follow-up, and patient compliance with recommended lens cleaning and disinfection, OrthoK is a safe and effective method to slow axial elongation in children.

Vision-related quality of life with myopia management: A review.

The disease of myopia has come into focus as a worldwide public health concern. Myopia has shown increasing prevalence, incidence at earlier age and progression to a higher degree. Progressive increase in degree of myopia is strongly associated with increase in axial length of the eye. Various interventions have been shown to slow axial elongation in children. These interventions have been studied to assess efficacy in slowing axial elongation and correction of vision. In addition, research into quality of vision, risk of adverse events, overall safety and impact on vision-related quality (VR-QoL) of life has been pursued. In contrast, studies have been published to demonstrate the risks of myopia, high myopia and increased axial length. This review will discuss VR-QoL assessment on the most effective and most commonly prescribed interventions to slow axial elongation and myopia progression. The patient attributes considered are VR-QoL scores from validated instruments. The development and use of validated survey instruments to assess the patient-reported outcomes is discussed. The review demonstrates that there are numerous factors that may impact VR-QoL to evaluate in the decision-making process when eye care providers consider when, how and if to prescribe myopia management (MM) for children with myopia.

The Effect of Treatment Zone Decentration on Myopic Progression during Or-thokeratology.

Purpose: To evaluate the relationship between magnitude of orthokeratology (OrthoK) treatment zone decentration and 2-year axial length (AL) elongation in myopic children.Methods: One-hundred and one Chinese children who wore OrthoK contact lenses for 2 years. The magnitude and direction of the OrthoK treatment zone center from the entrance pupil center were recorded after 3 and 24 months of lens wear along with AL measurement. Stepwise multiple linear regression analysis was performed to assess which factors significantly affected an increase in AL.Results: After 3 and 24 months of OrthoK treatment, the mean (± standard deviation [SD]) magnitude of the OrthoK treatment zone decentration was 0.64 ± 0.38 mm and 0.68 ± 0.32 mm, respectively. There were no significant differences between the two time points (P > .05). After 2 years of OrthoK contact lenses wear, the mean (± SD) AL growth was 0.36 ± 0.34 mm. The axial elongation was slightly correlated with baseline age of subjects (r = -0.073, P < .001), baseline spherical equivalent refractive error (r = -0.088, P < .001) and magnitude decentration of treatment zone (r = -0.190, P = .027).Conclusions: The decentration of OrthoK treatment zone stabilizes after 3 months of lens wear and slightly decreases AL growth.

The official guide to scleral lens terminology.

PURPOSE: In absence of scleral lens standards, this article aims to provide an official definition of terms related to scleral lens fitting and manufacturing, in order to make more uniform the use of appropriate terms when describing, writing or lecturing about scelral lenses. Adoption of a common terminology may also favor more fruitful exchanges between eyecare practitioners and manufacturers. METHODS: A committee of 12 advances scleral lens clinicians met and develop a list of terms related to scleral lens fit and manufacturing. Litterature review was made using PubMed database with the keywords "scleral lenses" and "terminology". Other related publications such as textbooks were also considered valid references. Validation of the terms selected and their suggested definition was made by consultation of other experts in the field, over 2 years. A final version was adopted by the Scleral Lens Education Society late in 2018. RESULTS: This article contains three main sections. Section I provides the definition of a scleral lens. Section II addresses the general terminology habitually applied to contact lens field but in the context of scleral lens usage. Finally, Section III suggests a decription of terms specifically used when fitting or manufacturing scleral lenses. At the end, recommendations are made to manufacturers about the essential elements to provide to eyecare practitioners in order to help them understanding the lens design and to customize their fit. CONCLUSION: A common language is key to advancing the science and clinical practice of scleral lens fitting. The current terminology will help standardize this field, helping eyecare practitioners, educators, speakers and manufacturers to talk with the same language.

Comparison of four different orthokeratology lenses in controlling myopia progression.

PURPOSE: To compare axial length (AL) elongation in myopic children with four Orthokeratology (OrthoK) lenses and spectacles. METHODS: The medical records of 266 patients (532 eyes) who were fitted with OrthoK lenses or spectacles (control group) were reviewed. Data collection included baseline age, gender, baseline objective sphere and cylinder, baseline flat and steep corneal meridian power, corneal asphericity coefficient (Q value), AL at baseline and after 1-year, and 2-years of OrthoK or spectacle wear analyzed using analysis of repeated measures data ANOVA. Stepwise linear regressions between the changes in AL after 2 years relative to baseline parameters were calculated for the OrthoK and control groups separately. RESULTS: The baseline subject parameters for each of the four OrthoK lenses were not statistically different. Statistically significant differences between time points were found between 12- and 24- months (all P < 0.05). AL growth was slower in all OrthoK groups than in the control group (all P < 0.05). AL grew 0.081±0.034 mm per year slightly less than average with Essence compared to the Mouldway OrthoK group (P = 0.019). The coefficient of regression weakly expressed between the increases in AL over 2-years study period and baseline spherical equivalent refraction was 0.065 in Essence, 0.079 in Euclid and 0.087 in Mouldway. The coefficient of regression was also weakly between age and the increases AL over 2-years study period and baseline age in all groups. CONCLUSION: Different OrthoK lenses differ minimally in slowing axial elongation effectively in myopic children during 2-years lens wear.

Posterior cornea and thickness changes after scleral lens wear in keratoconus patients.

PURPOSE: To evaluate the changes in the corneal thickness, anterior chamber depth and posterior corneal curvature and aberrations after scleral lens wear in keratoconus patients with and without intrastromal corneal ring segments (ICRS). METHODS: Twenty-six keratoconus subjects (36.95 ±â€¯8.95 years) were evaluated after 8 h of scleral lens wear. The subjects were divided into two groups: those with ICRS (ICRS group) and without ICRS (KC group). The study variables evaluated before and immediately after scleral lens wear included corneal thickness evaluated in different quadrants, posterior corneal curvature at 2, 4, 6 and 8 mm of corneal diameter, posterior corneal aberrations for 4, 6 and 8 mm of pupil size and anterior chamber depth. RESULTS: There was a statistically significant corneal thinning (p < 0.05) in the inferior region of the KC group and in the superior region of the ICRS group. No change (p > 0.05) in the anterior chamber depth was found. The KC group showed a steepening (p < 0.05) in the temporal quadrant and a flattening that mainly affected to the superior-nasal quadrant. The ICRS group showed a steepening (p < 0.05) that mainly affected to the superior-nasal quadrant. Regarding posterior corneal aberrations, only changes (p < 0.05) in Z4 for 8 mm and Z8 for 4 mm were found in the KC group. CONCLUSIONS: Short-term scleral lens wear showed a thinning of the cornea and changes in the posterior corneal curvature affects different regions in keratoconus patients with and without ICRS.

Anterior Corneal Curvature and Aberration Changes After Scleral Lens Wear in Keratoconus Patients With and Without Ring Segments.

OBJECTIVE: To evaluate changes in the anterior corneal curvature and aberrometry after scleral contact lens wear in keratoconus (KC) subjects with and without intracorneal ring segments (ICRS). METHODS: Twenty-six subjects diagnosed with keratoconus were selected to participate in the study. Subjects were divided into 2 groups, those with ICRS (KC-ICRS group) and those without ICRS (KC group). Subjects were instructed to wear 16.5-mm scleral lenses for 8 hours. Topographic and aberrometric parameters were evaluated before lens wear and immediately after lens removal. Anterior corneal curvature was evaluated at corneal diameters of 2, 4, 6, and 8 mm, and corneal aberrations were measured at 4-, 6-, and 8-mm pupil diameters. RESULTS: The mean age of subjects was 36.95±8.95 years. In KC group, there was a statistically significant flattening of the central corneal curvature, from 6.98 to 7.09 mm (P<0.05). No changes were found in the central corneal curvature in the KC-ICRS group. The KC group showed anterior corneal curvature flattening, mainly in the nasal quadrant. The KC-ICRS group showed flattening primarily in the inferior hemisphere. In the KC group, spherical aberration for 6-mm pupil increased significantly. In the KC-ICRS group, changes in aberrations were significant for high-order root mean square at 4- and 6-mm pupil diameters (P<0.05), for oblique astigmatism for 4 mm and 6 mm, and for vertical coma for 4-mm pupil (P<0.05). CONCLUSION: Short-term scleral lens wear showed flattening of the anterior corneal surface in all subjects. In the KC group, the flattening was more pronounced in the nasal quadrant while changes were more pronounced inferiorly in KC-ICRS group.

The Role of Orthokeratology in Myopia Control: A Review.

The prevalence of myopia and high myopia has significantly increased worldwide and in the United States. The serious implications of these trends are being recognized. Myopia is not just a minor inconvenience requiring vision correction with glasses or contact lenses, but a disease process creating significant risk of serious vision-threatening eye disease. Various methods of treatment for myopia and myopic progression have been prescribed and studied in effort to find one that is effective, safe, and that patients will be compliant with. Numerous peer-reviewed studies have shown orthokeratology (OrthoK) is effective in slowing myopic progression. This review article covers the development of OrthoK, its mechanism of action, its evolution, and refinement from a refractive option to its use as a mean of slowing myopic progression. After detailing patterns of myopia progression, a description of theories and studies as to how OrthoK slows myopia progression in children is also explained. The review will focus on progression of myopia and the use of OrthoK to slow myopia progression after myopia has been diagnosed.

Orthokeratology and Contact Lens Quality of Life Questionnaire (OCL-QoL).

OBJECTIVES: To develop a quality of life (QoL) instrument for patients fitted with Orthokeratology (OrthoK) and other modalities of contact lenses. METHODS: A 45-item pilot questionnaire was developed from an extensive literature review, focus groups, and interviews. Subsequently, 234 participants fitted with contact lenses (OrthoK, soft lenses, and gas permeable lenses) or spectacles completed the pilot questionnaire. Rasch analysis was used to assess the psychometric properties in terms of person separation, item fit statistics, category threshold ordering, differential item functioning (DIF), and targeting. A subset of participants completed the final questionnaire twice (1 week apart) and the repeatability assessed (within-subject standard deviation). The Spearman rank-order correlation coefficient between the questionnaire score and binocular visual acuity was calculated to assess construct validity. RESULTS: Inspection of category probability curves suggested that one category was underused and the response options were collapsed. Furthermore, Rasch analyses indicated 22 items misfitted the model and were removed. The final questionnaire contained 23 items with a person separation of 2.18, item fit statistics within the range 0.83 to 1.15, targeting 1.05 logits, and no significant DIF (<0.8 logits). The repeatability (Sr) was 4.21 and there was no correlation between questionnaire scores and binocular visual acuity (rs=0.03, P=0.65). CONCLUSIONS: The Orthokeratology and Contact Lens Quality of Life Questionnaire demonstrated excellent psychometric properties and is capable of measuring vision-related QoL in patients fitted with various forms of contact lenses including OrthoK lenses. The tool is scored on a 0 to 100 interval level scale with higher scores indicating better QoL.

Axial Length Measurement: PalmScan Versus IOLMaster.

OBJECTIVE: To compare axial length measurements taken on the handheld Micro Medical Devices (MMD) PalmScan with those taken with the Carl Zeiss Meditec IOLMaster. METHODS: Sixty subjects had IOLMaster performed by a single operator to measure axial length in both eyes. Subjects then had axial length measurements taken by a different single operator with the MMD device. Each operator was masked to the other's results. Independent statistical analysis was performed to compare results. RESULTS: Sixty subjects had both eyes measured with each device for a total of 120 eyes. Subjects were categorized into 1 of 3 groups with 20 subjects each, 40 eyes in each group. Subjects in group A were wearers of overnight corneal reshaping, group B were soft lens wearers, and group C were noncontact lens wearers. Overall, the measures of axial length from IOLMaster and MMD were highly correlated (correlation = 0.93, P < 0.001, n = 120). Similarly, measures within each group between the 2 methods were highly correlated: group A (correlation = 0.94, P < 0.0001, n = 40), group B (correlation = 0.90, P < 0.0001, n = 40), and group C (correlation = 0.98, P < 0.001, n = 40). Results were highly correlated between the two devices. Data scatter plots and Bland-Altman plots were generated, showing that although there was good agreement between the methods, the MMD almost always measured the axial length smaller than the IOLMaster (median difference = 0.21 mm, mean difference ± SD = 0.26 ± 0.42 mm). CONCLUSIONS: The MMD is a convenient, reliable, and portable device to measure axial length. It can be used to monitor axial length in patients over time.

Long-term clinical outcomes for overnight corneal reshaping in children and adults.

PURPOSE: To retrospectively evaluate outcomes of overnight corneal reshaping (OCR) in children aged 12 years or younger compared to children older than 12 years and adults at one practice to establish the efficacy and safety of OCR during a period of 51 months. METHODS: Examination records of OCR patients were reviewed for pretreatment data, including manifest refraction, keratometric readings, topography, corneal staining, and age at beginning OCR. Posttreatment records were reviewed for manifest refraction, unaided visual acuity, keratometric readings, topography, corneal staining, adverse events, and duration of OCR lens wear. RESULTS: Records of 296 OCR patients were evaluated. One hundred fifty-four (52.0%) patients were 12 years old or younger. Sixty-eight percent of all patients in the study were Asian, and almost 95% of the patients aged 12 years or younger were Asian. The patients aged 12 years or younger had a mean original spherical equivalent refractive error of -3.50 +/- 1.50 diopters (D). The patients older than 12 years had a mean original spherical equivalent refractive error of -3.20 +/- 1.50 D. Refractive changes were similar between the group aged 12 years or younger and the group older than 12 years (3.30 +/- 1.40 D vs. 3.10 +/- 1.40 D) (P=0.14). The mean unaided, binocular logMAR visual acuity was 0.03 +/- 0.06 (i.e., 20/20) for the group aged 12 years or younger and 0.02 +/- 0.07 (i.e., 20/20) for the group older than 12 years. There were three adverse events during the study that did not result in a loss of best-corrected visual acuity. A total of 507 patient-years of wear was represented in the study. CONCLUSIONS: OCR resulted in comparable safety and efficacy in temporarily reducing myopia for children younger than 12 years as it is for children older than 12 years and adults.

Synergeyes versus soft toric lenses: vision-related quality of life.

PURPOSE: The purpose of this study is to contrast the clinical and vision-related quality of life outcomes between Synergeyes, a hybrid contact lens, and Bausch & Lomb Soflens 66 Toric contact lenses in a cross-over design. Also, to determine subject preference of one mode of lens wear over the other. METHODS: The Synergeyes lens has a central rigid gas permeable portion made of Paragon HDS100 material (paflufocon D) bonded to the nonionic hydrophilic skirt material of 27% water (PolyHEMA hem-iberfilcon A). The Soflens 66 Toric lens is made of a nonionic hydrophilic 66% water (alphafilcon A) material. Subjects age 18 years and older with spherical refractive error between -0.50 and -8.00 D and astigmatism correction of -0.75 to -3.50 D were randomly assigned to wear one mode of contact lens for 1 month then wear the alternate mode for 1 month. Follow-up visits were done at 1 and 4 weeks. Data gathered at these visits included high-contrast log MAR distance visual acuity, average wearing time, comfortable wearing time, over-refraction, and slit lamp observations for corneal edema, conjunctival hyperemia, and corneal staining. At each visit, subjects were asked to rate overall comfort, dryness, and comfortable wearing time. Subjects were asked to complete the NEI-RQL-42 questionnaire at the end of each lens wearing period. Upon completion of both lens wearing modes, subjects were asked to choose their preferred mode. RESULTS: Fifty subjects completed the study; 22 (44%) preferred the Synergeyes lenses, and 28 (56%) preferred the Soflens 66 Toric soft lenses. Measured visual acuity was significantly better with the Synergeyes lenses. Of the 13 attributes analyzed in the RQL-42, a statistically significant difference between the two modes was found in only one category, "symptoms." In that category, subjects indicated fewer symptoms when wearing soft lenses. The subjects' ratings also showed significantly more comfort while wearing the soft toric lenses. CONCLUSIONS: Bausch & Lomb Soflens 66 Toric lenses were more comfortable and were perceived to produce less symptoms of dryness, itchiness, and lens awareness than Synergeyes lenses. Synergeyes lenses gave better visual acuity than the soft toric lenses.

Corneal reshaping: is it a good alternative to refractive surgery?

PURPOSE OF REVIEW: To review current literature on overnight corneal reshaping and present this mode of vision correction in its current state. RECENT FINDINGS: Overnight corneal reshaping uses specially designed rigid gas-permeable contact lenses. It is effective in temporarily reducing or eliminating low to moderate myopia. This nonsurgical mode of vision correction allows for good unaided vision during waking hours. There are reports of young patients experiencing serious adverse events, particularly bacterial and Acanthamoeba keratitis while using these lenses, although incidence rates are unknown. SUMMARY: Overnight corneal reshaping is an alternative to refractive surgery and must continue to be studied and monitored to establish its safety.

Overnight corneal reshaping versus soft disposable contact lenses: vision-related quality-of-life differences from a randomized clinical trial.

PURPOSE: The purpose of this article is to evaluate patients' visual acuity, symptoms, and perceptions of vision-related quality of life in a randomized crossover clinical trial of overnight corneal reshaping (OCR) and daily wear soft lenses (SCL). METHODS: Qualified subjects were randomly assigned to wear one mode of contact lens for 8 weeks and then, after a washout period, they wore the alternate mode for 8 weeks. On concluding each contact lens wear mode, subjects completed the NEI-RQL42 questionnaire. During the SCL mode, subjects wore lenses during their waking hours. During the OCR mode, subjects wore lenses only while sleeping. Soft lenses were Biomedics 55 2-week disposable lenses. OCR lenses were CRT lenses by Paragon. (Three subjects were fit with custom-designed OCR lenses in Boston XO material, manufactured by Art Optical.) LogMAR acuity was measured and slit lamp evaluation was performed at specified intervals during follow up. After completing both phases of the study, patients chose which mode they preferred. RESULTS: Of 81 enrolled patients, 65 completed both phases and 16 dropped out during the study. Significant differences (p<0.01) favoring SCL wear included better visual acuity and less trouble with glare. Significant differences (p<0.01) favoring OCR wear included less activity limitations, less trouble with symptoms, and less dependence on refractive correction. Of 65 completing both phases, 44 preferred the OCR lenses and 21 preferred the soft lenses. Subjects who preferred the OCR lenses were less myopic and had steeper K readings at baseline, and showed less difference between visual acuity during OCR wear and visual acuity with SCL. CONCLUSION: In subjects with mild myopia who experienced both SCL and OCR, better visual acuity and less glare resulted from SCL wear, whereas activity limitations, symptoms, and dependence on refractive correction were less troublesome with OCR wear. When the study was completed, 67.7% chose OCR lenses worn only while sleeping, whereas 32.3% preferred 2-week disposable soft lenses worn during the day as their preferred correction.

Kareem's Version.

If the issues of communication, timing and truth-telling in all the stages of life continue to present some of the most thoughtful challenges in a clinician's practice, this is especially true in end of life care. Michael Lipson's narrative of a child's death and his subsequent dual reflections on truth and the eternal fill me with a burning question. Why wait for "Sister Death" to arrive to live with this kind of presence-of-being? This expansion "beyond?" Wouldn't it deepen and enrich our lives to live with this awareness or capacity right now? -Therese Schroeder-Sheker, The Chalice of Repose Project.

Overnight corneal reshaping versus soft daily wear: a visual quality of life study (interim results).

PURPOSE: To evaluate patients' perceptions of visual quality of life differences in a crossover study with two different modes of contact lens wear: overnight corneal reshaping (OCR) lenses and daily-wear soft lenses. METHODS: Qualified subjects wore one mode of contact lens for 8 weeks and then completed the National Eye Institute RQL-42 questionnaire. After a washout period, subjects wore the alternate mode for 8 weeks followed by the questionnaire. During soft lens mode, subjects wore lenses during their waking hours. During the overnight corneal reshaping mode, subjects wore lenses only while sleeping. Soft lenses were Biomedics 55 2-week disposable lenses. OCR lenses were Corneal Refractive Therapy (CRT) lenses by Paragon. Subjects were randomly assigned to wear soft contact lenses or OCR lens first. After completing both phases of the study, patients were asked to choose which mode they preferred. RESULTS: Interim results show that of 74 subjects enrolled, 45 have completed both phases; 14 have dropped out of the study; and 15 are still in process. Of the 45 subjects completing both phases, 32 have chosen to continue with the CRT lenses, and 13 have chosen to stay with the soft lenses. Logarithm of the minimum angle of resolution visual acuity was 0.06 (20/20) for soft contact lenses and 0.11 (20/25) for CRT lenses. RQL-42 scoring for overall satisfaction was 81.33 for OCR lenses and 74.67 for soft lenses. CONCLUSIONS: Although overall satisfaction scores and vision were comparable between the two modes, 71% of the subjects elected to stay with CRT lenses. In this study of patients who experienced both modes of lens wear, 71% chose OCR lenses.