Marjorie J. Rah

Overnight orthokeratology: preliminary results of the Lenses and Overnight Orthokeratology (LOOK) study.

Background. The Lenses and Overnight Orthokeratology (LOOK) study is a pilot study designed to learn the procedures of orthokeratology lens fitting in preparation for a planned larger clinical trial and to obtain data with which to calculate a sample size for that larger study. Data are presented for the first 3 months of the LOOK study. Methods. Sixty subjects were enrolled in this multicenter pilot study to evaluate the success and safety of treatment with overnight orthokeratology contact lenses. Refractive error, corneal topography, and biomicroscopic data were collected to determine the amount of refractive error change achieved, corneal changes, and a safety profile of overnight wear of reverse geometry rigid gas permeable lenses for orthokeratology. Results. Of the 60 subjects enrolled, 46 completed the 1-month visit, and 31 completed the 3-month visit. The mean change in spherical equivalent manifest refraction from baseline to the morning 3-month visit was 2.08 ± 1.11 D in the right eye and 2.16 ± 1.05 D in the left eye. At the 3-month morning visit, 74% of right eyes and 61% of left eyes had 20/20 unaided visual acuity. No corneal infiltrates or ulcers were noted in any subjects. Observations of fluorescein staining of the cornea, imprinting, and microcysts were noted in some patients at the 3-month visit. Conclusions. The preliminary results of the LOOK study indicate that improvement in unaided visual acuity can be attained for at least 6 h after lens removal. The short-term safety and efficacy of the procedure appear to be favorable; however, future studies are needed to determine the long-term outcomes of treatment.

The Children's Overnight Orthokeratology Investigation (COOKI) Pilot Study

Purpose. Innovations in contact lens materials and designs allow patients to wear contact lenses during sleep to flatten the cornea and temporarily to reduce myopic refractive error and improve unaided visual acuity. We conducted the Children’s Overnight Orthokeratology Investigation (COOKI) pilot study, a case series, to describe the refractive error and visual changes, as well as the slitlamp observations associated with overnight orthokeratology in children, over a period of 6 months. Methods. Twenty-nine 8- to 11-year-old children with myopia between −0.75 and −5.00 D and <−1.50 D corneal toricity were fitted with corneal refractive therapy contact lenses (Paragon Vision Sciences, Mesa, AZ). They were examined within 1 hour of awakening and about 6 hours later at 1 day, 1 week, 2 weeks, 1 month, 3 months, and 6 months after the first night of contact lens wear. At each visit, the logarithm of the minimum angle of resolution (logMAR) visual acuity, manifest refraction, slitlamp examination, and corneal topography were performed. Results. Twenty-three subjects completed the 6-month study. Three subjects decided not to wear contact lenses, two did not achieve acceptable fits, and one moved from the area. At the 6-month afternoon visit, the mean ± SD uncorrected high-contrast visual acuity was +0.08 ± 0.15 logMAR (Snellen equivalent, 20/24), and the mean ± SD spherical equivalent refraction was −0.16 ± 0.66 D. The corneas of three-fifths of the subjects showed mild staining at the morning visit, and one-third of the patients showed mild corneal staining at the afternoon visit. The most common type of stain was central punctate staining. No subjects experienced lasting adverse visual effects from cornea-reshaping contact lens wear during the study period. Conclusions. Overnight cornea-reshaping contact lenses are efficacious for young myopic patients, and no children experienced a serious adverse event during the study.

A review of hyaluronan and its ophthalmic applications

Hyaluronan (HA) is a naturally occurring, biocompatible polysaccharide with unique viscoelastic and hygroscopic properties. Its role as a natural lubricant and its excellent water-retaining properties make it well-suited for use in ophthalmic products. Many reports have been written describing the various uses of HA. The purpose of this report is to review the uses of HA in the anterior segment of the eye, more specifically, its use in the treatment of dry eye syndrome, and in contact lenses and contact lens care systems.

Randomized Trial of the Effect of Contact Lens Wear on Self-Perception in Children

Purpose. To determine whether contact lens wear affects children’s self-perceptions. Methods. The Adolescent and Child Health Initiative to Encourage Vision Empowerment Study was a randomized, single-masked trial conducted at five clinical centers in the United States. Subjects were 8- to 11-year-old myopic children randomly assigned to wear spectacles (n = 237) or soft contact lenses (n = 247) for 3 years. The primary endpoint was the Self-Perception Profile for Children Global Self-Worth scale. Secondary outcomes included the Physical Appearance, Athletic Competence, Scholastic Competence, Behavioral Conduct, and Social Acceptance Self-Perception Profile for Children scales. Results. Global self-worth was not affected by contact lens wear [analysis of variance (ANOVA), difference = 0.06; 95% CI, −0.004 to 0.117]. Physical appearance (ANOVA, difference = 0.15; 95% CI, 0.07 to 0.22), athletic competence (ANOVA, difference = 0.08; 95% CI, 0.01 to 0.15), and social acceptance (ANOVA, difference = 0.10; 95% CI, 0.03 to 0.17) were all greater for contact lens wearers. Conclusions. Although contact lens wear does not affect global self-perceptions of 8- to 11-year-old myopic children their physical appearance, athletic competence, and social acceptance self-perceptions are likely to improve with contact lens wear. Eye care practitioners should consider the social and visual benefits of contact lens wear when choosing the most appropriate vision correction modality for children as young as 8 years of age.

The contact lens and myopia progression (CLAMP) study: design and baseline data.

Background. Although previous contact lens myopia control studies indicate that rigid contact lenses slow the progression of myopia in children, they have all suffered from limitations that challenge the significance of their results. The Contact Lens and Myopia Progression (CLAMP) Study addresses the limitations of previous studies and attempts to correct them by implementing alternative Study designs. The CLAMP study also measures all the ocular components to examine the potential mechanism of treatment effect. Methods. Eligible children were fitted with rigid gas-permeable contact lenses and enrolled in a run-in period to determine whether they were able to adapt to rigid contact lens wear. Subjects who successfully completed the run-in period were randomly assigned to wear rigid contact lenses or soft contact lenses for the remainder of the 3-year study. The primary outcome measure will be the 3-year change in cycloplegic autorefraction; the secondary outcome measures will include the 3-year change in axial length, peripheral autorefraction, crystalline lens curvatures, corneal curvature and thickness, accommodation, and intraocular pressure, which are being measured annually. Results. We examined 148 eligible subjects who participated in the run-in period. Of the 148 eligible subjects, 116 (78.4%) were able to adapt to rigid contact lens wear and were enrolled in the CLAMP Study. The mean age of the participants at the baseline visit was 10.5 years, and 59.5% were girls. At the randomization visit, the mean (±SD) spherical equivalent refractive error in the right eye was −2.09 ± 0.89 D, the mean central curvature of the right cornea by videokeratography was 44.5 ± 1.3 D, and the mean axial length of the right eye was 24.13 ± 0.71 mm. Conclusions. Four of five children aged 8- to 11-years-old were able to adapt to rigid gas-permeable contact lens wear. The CLAMP Study aims to further clarify the effect of rigid gas-permeable contact lenses on myopia progression in children.

Recovery of refractive error after corneal refractive therapy.

Purpose. To describe the regression of treatment (i.e., return toward baseline refractive error findings) after treatment with corneal refractive therapy (CRT). Methods. After 6 to 9 months of treatment by a standardized protocol for CRT (application of high-Dk, proximity control, return zone contact lenses for overnight reduction of myopia), refractive error was measured within hours after awaking and at 8, 24, 48, and 72 hours. Comparison of regression is analyzed in four categories of achieved treatment. Logarithm of the minimum angle of resolution visual acuity regression was also measured. Results. In general, refractive error returns to baseline after CRT for all measured ranges of refraction in the period of measurement of this study. Conclusions. The greater the magnitude of CRT treatment, the more rapid the recovery is to baseline refraction.

The Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) study design and baseline data.

Purpose. The purpose of this study was to describe the baseline characteristics of subjects and methods for a multicenter, randomized clinical trial to compare the effects of contact lens wear and spectacle wear on childrens self-perception. Methods. Eligible subjects are randomly assigned to wear glasses or contact lenses throughout the 3-year study. Self-perceptions are measured 1 month after randomization and every 6 months using the Self-Perception Profile for Children (SPPC). Childrens satisfaction with spectacles and refractive error-related visual quality of life are also measured using surveys developed for the study. Visual acuity, cycloplegic autorefraction, corneal curvature, and axial dimensions are measured annually. Results. Five clinical sites enrolled 484 subjects with a mean (± standard deviation [SD]) age of 10.4 ± 1.1 years. Approximately three-fifths of the subjects are girls, 47.1% of the subjects are white, 21.5% are black, and 21.5% are Hispanic. The mean (± SD) cycloplegic spherical equivalent autorefraction of the right eye is –2.38 ± 1.04 D, and the average (± SD) axial length of the right eye is 24.32 ± 0.77 mm. The average (± SD) Global Self-Worth score on the SPPC is 3.20 ± 0.62 on a scale from one (low perceived competence) to 4 (high perceived competence). The average (± SD) spectacle satisfaction is 59.1 ± 26.6 on a scale from zero (no satisfaction) to 100 (perfect satisfaction). The average refractive error-related quality of life score is 63.5 ± 12.8 on a scale from zero (poor quality of life) to 100 (excellent quality of life). Conclusions. Subjects enrolling in the ACHIEVE Study are an ethnically diverse group of young myopic children. Ocular characteristics of the sample are consistent with data presented in other randomized clinical trials evaluating treatments for myopic children. The data reported here represent the baseline data for a 3-year randomized clinical trial to investigate the effects of contact lens vs. spectacle wear on childrens self-perceptions.

Contact Lenses in Pediatrics (CLIP) Study: chair time and ocular health.

Purpose. Despite several studies that show 8- to 11-year-old children are capable of wearing a various contact lens modalities, parents often report that their eye care practitioner would not fit their child with contact lenses until the child was about 13 years old. We conducted the Contact Lenses in Pediatrics (CLIP) Study to compare contact lens fitting and follow-up between 8- to 12-year-old children and 13- to 17-year-old teenagers. Methods. At the baseline visit, all subjects underwent a contact lens fitting, including visual acuity, a manifest refraction, autorefraction, and biomicroscopy. Subjects then underwent contact lens insertion and removal training, which consisted of talking about contact lens care as well as inserting and removing a contact lens three times. Subjects returned for follow-up visits at 1 week, 1 month, and 3 months, and visual acuity, contact lens fit assessment, and biomicroscopy were performed. The time of the fitting, the insertion and removal training, and each follow-up visit were measured individually and added for a total chair time. Biomicroscopy examinations were conducted according to a standardized protocol. Results. We enrolled 84 children and 85 teens in the study. Of the 169 subjects, 93 (55.0%) were female, 78 (46.2%) were white, 44 (23.3%) were Hispanic, and 28 (17.6%) were black. The mean (± SD) total chair time for children was 110.6 ± 39.2 min, significantly more than 95.3 ± 25.2 min for teens (Student’s t-test, p = 0.003). Most of the difference was caused by insertion and removal training, which lasted 41.9 ± 32.0 min for children and 30.3 ± 20.2 min for teens (Student’s t-test, p = 0.01). The presence of conjunctival staining increased from 7.1% of the subjects at baseline to 19.9% of the subjects at 3 months (&khgr;2, p = 0.0006), but the changes were similar between children and teens. No other biomicroscopy signs increased significantly over the 3-month period. Conclusions. The total chair time for children is approximately 15 min longer than teens, but most of that difference is explained by longer time spent teaching children insertion and removal. Because insertion and removal is generally taught by staff members, the eye care practitioner’s time with the patient is similar between children and teens. Furthermore, neither children nor teens experienced problems related to contact lens wear during the study. Eye care practitioners should consider routinely offering contact lenses as a treatment option, even for children 8 years old.

Adverse corneal events associated with corneal reshaping: a case series.

Purpose. This case series presents the first documented cases of infectious ulcers associated with overnight orthokeratology in North America and other less serious complications associated with overnight corneal reshaping. Case Reports. Five cases of adverse corneal events associated with corneal refractive therapy are described: two cases of microbial keratitis, one case of infiltrates, one case of toxic keratitis, and one corneal abrasion. Conclusions. Corneal compromise and poor compliance can cause adverse events with corneal reshaping. The need for ongoing patient education is important not only for pediatric contact lens patients, but also for adults.

Vision specific quality of life of pediatric contact lens wearers.

Purpose. Several studies have shown that children are capable of wearing and caring for contact lenses, but it is not known whether the benefits outweigh the risks associated with contact lens wear. The purpose of this article is to compare the vision-related quality of life benefits of children randomized to wear spectacles or contact lenses for 3 years using the Pediatric Refractive Error Profile. Methods. The Pediatric Refractive Error Profile was administered to 484 children who wore glasses at baseline. The children were then randomly assigned to wear contact lenses (n = 247) or spectacles (n = 237) for 3 years. The survey was administered at the baseline examination, at 1 month, and every 6 months for 3 years. Results. During 3 years, the overall quality of life improved 14.2 ± 18.1 units for contact lens wearers and 2.1 ± 14.6 units for spectacle wearers (p < 0.001). In all scales except the visual performance scales (Distance Vision, Near Vision, and Overall Vision), the quality of life improved more for older subjects than younger subjects. The three scales with the largest improvement in quality of life for contact lens wearers were Activities, Appearance, and Satisfaction with Correction. Conclusions. Myopic children younger than 12 years of age report better vision-related quality of life when they are fit with contact lenses than when they wear glasses. Older children, children who participate in recreational activities, children who are motivated to wear contact lenses, and children who do not like their appearance in glasses will benefit most.