A comparison of spectacle and contact lens wearing times in the ACHIEVE study.

PURPOSE: The aim was to compare vision correction wearing time between myopic children and teenagers in a clinical trial of contact lenses and spectacles. METHODS: Parents of subjects in the Adolescent and Child Health Initiative for Vision Empowerment (ACHIEVE) study provided wearing times for spectacle and contact lens wear. Hours wearing primary correction and total correction were compared between the two treatment groups. Other factors hypothesised to be associated with wearing time were analysed. RESULTS: The average wearing time of the primary correction differed significantly with the wearing time for the spectacles group being 91.5 hours per week compared to 80.3 hours per week for the contact lens wearers (p < 0.0001). Total correction time was slightly higher for the contact lens wearers, 97.5 hours per week, after accounting for time wearing spectacles. Higher refractive error was strongly related to longer wearing times (p < 0.0002). Age and treatment group were associated with wearing time (p = 0.005). Young contact lens wearers wore their lenses less than young spectacle wearers and older contact lens wearers. Low scores on an appearance quality-of-life scale were associated with longer wearing time in spectacle wearers compared to the low- and high-scoring contact lens wearers. Gender, spectacle satisfaction and activities were not related to wearing time. CONCLUSIONS: While contact lens wearers, on average, wear their contact lenses less than spectacle wearers, they spend roughly the same amount of time wearing a refractive correction. Higher refractive error resulted in longer wearing times for both spectacle and contact lens wearers. Younger contact lens wearers wore their contact lenses for shorter periods than the spectacle wearers, but still wore them, on average, 74.4 hours per week (about 10 hours per day), suggesting that contact lenses are a viable alternative mode of correction for children.

Purchase of contact lenses and contact-lenses-related symptoms following the Contact Lenses in Pediatrics (CLIP) Study.

BACKGROUND: The rate and reasons for discontinuation of contact lens wear by young patients are not well known. The Contact Lenses in Pediatrics (CLIP) Study surveyed participants 3 months after the final study visit to determine the percentage of participants who continued to wear contact lenses after study conclusion. The factors associated with continued contact lens wear and differences in behaviors between the children and teens were also determined to provide insights to practitioners who provide refractive correction for patients in those age groups. METHODS: Three months after the CLIP Study completion, participants and parents returned mailed surveys that assessed post-study lens purchase and symptoms related to contact lens wear if contact lenses wear had been continued. Responses were compared between the children and teens using chi(2) or Fisher's exact test. RESULTS: Almost 92% of the surveys were returned. Eighty percent of teens' parents reported purchasing lenses after the study, vs. 63% of the children's parents (p=0.02). Symptoms reported at the last study visit were not significantly associated with future purchase, though there was a trend towards more light sensitivity in those who did not purchase more contact lenses (23.1% vs. 11.8%). Satisfaction with contact lenses was high among both those purchasing additional contact lenses and those who did not. Both children and teens reported similar frequencies of symptoms such as burning, itching or tearing eyes 3 months following study completion. Teens reported having contact-lens-related dry eyes more frequently than children. CONCLUSIONS: A large proportion of children and an even higher proportion of teens continued wearing their lenses 3 months after completing the CLIP Study. Children and teens reported similar contact lens comfort and low frequencies of most symptoms, though teens experienced more dry-eye symptoms. Overall, reports of symptoms in this sample were lower than had been reported in adult populations by other investigators.

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.

A randomized trial of the effect of soft contact lenses on myopia progression in children.

PURPOSE: Soft contact lenses have been reported to increase the progression of myopia. The purpose of this study was to determine whether soft contact lenses affect the progression of myopia in children. METHODS: Children between the ages of 8 and 11 years with -1.00 to -6.00 D myopia and less than 1.00 D astigmatism were randomly assigned to wear soft contact lenses (n = 247) or spectacles (n = 237) for 3 years. Refractive error and corneal curvatures were measured annually by cycloplegic autorefraction, and axial length was measured annually by A-scan ultrasound. Multilevel modeling was used to compare the rate of change of refractive error, corneal curvature, and axial length between spectacle and contact lens wearers. RESULTS: There was a statistically significant interaction between time and treatment for myopia progression (P = 0.002); the average rate of change was 0.06 D per year greater for contact lens wearers than spectacle wearers. After 3 years, the adjusted difference between contact lens wearers and spectacle wearers was not statistically significant (95% confidence interval [CI] = -0.46 to 0.02). There was no difference between the two treatment groups with respect to change in axial length (ANCOVA, P = 0.37) or change in the steepest corneal curvature (ANCOVA, P = 0.72). CONCLUSIONS: These data provide reassurance to eye care practitioners concerned with the phenomenon of "myopic creep." Soft contact lens wear by children does not cause a clinically relevant increase in axial length, corneal curvature, or myopia relative to spectacle lens wear. (ClinicalTrials.gov, NCT00522288.).

Benefits of contact lens wear for children and teens.

PURPOSE: Children are not offered elective contact lenses as a treatment option for refractive error nearly as often as teens are. The purpose of this report was to examine the benefits of contact lens wear for children and teens to determine whether children benefit as much as teens. If they do, children should routinely be offered contact lens wear as a treatment for refractive error. METHODS: Neophyte contact lens wearers were categorized as children (8-12 years of age) or teens (13-17 years of age). They completed the Pediatric Refractive Error Profile (PREP), a pediatric quality-of-life survey for subjects affected only by refractive error, while wearing glasses; then they were fitted with silicone hydrogel contact lenses. One week, 1 month, and 3 months after receiving contact lenses, the subjects completed the same PREP survey. Subjects also completed questions regarding wearing time and satisfaction with contact lenses during specific activities. RESULTS: The study enrolled 169 subjects at three clinical centers. Ninety-three (55%) of the subjects were girls; 78 (46%) were white; and 44 (26%) were Hispanic. After wearing contact lenses for 3 months, the overall PREP score increased from 64.4 for children and 61.8 for teens while wearing glasses to 79.2 for children and 76.5 for teens. The improvement from baseline to 3 months was significant for children and teens (P<0.0001 for both groups), but there was not a significant difference in improvement between children and teens (P>0.05). The areas of most improvement were satisfaction with correction, activities, and appearance. CONCLUSIONS: Contact lenses significantly improved the quality of life, as reported by children and teens using the PREP, and there was not a difference in improvement between children and teens. Contact lens wear dramatically improves how children and teens feel about their appearance and participation in activities, leading to greater satisfaction with their refractive error correction. The improvement in quality of life after contact lens wear indicates that children should be offered contact lenses as a treatment for refractive error as routinely as teens.

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 (chi2, 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.

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 children's 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). Children's 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 children's self-perceptions.