Visual activity and its association with myopia stabilisation.

PURPOSE: To evaluate the association between outdoor and nearwork activities at baseline and myopia stabilisation by age 15 in the Correction of Myopia Evaluation Trial (COMET). METHODS: Correction of Myopia Evaluation Trial enrolled 469 children (ages: 6-11 years) with spherical equivalent myopia between -1.25 and -4.50 D, who were randomised to progressive addition or single vision lenses and followed for 5 years in their original lenses. At baseline, families recorded the child's outdoor and nearwork activities for 3 days within a week. Weekly hours spent in nearwork and outdoor activities were calculated for each participant. Refractions collected over 11 years were fit using the Gompertz function to determine each participant's myopia stabilisation age. Myopia for each child was then categorized as stable/not stable by age 15. RESULTS: Half (233/469) of participants had usable baseline activity diaries and refraction data that could be fit with the Gompertz function, 59.7% (139/233) had stable myopia by age 15 and 40.3% had myopia that was not yet stable. The frequency of stable myopia was similar for the two categories (median split) of outdoor activities: 60% (71/118) for ≤9.0 hours/week(-1) and 59% (68/115) for >9.0 hours/week(-1) . 56% (64/114) of children reporting >21.0 h of baseline weekly nearwork activity had stable myopia by age 15 compared to 63% (75/119) with ≤21.0 h of near work (adjusted OR = 0.74; 95% CI: 0.43-1.29). Using baseline nearwork as a continuous variable, the multivariable odds ratio for the association between baseline nearwork hours and stabilisation by age 15 is 0.98: 95% CI: 0.96-1.00, a result trending towards significance. CONCLUSION: While time spent in outdoor activities in childhood does not appear to be related to myopia stabilisation by age 15, less near work activity might potentially be associated with myopia stabilisation by that age.

Myopia, contact lens use and self-esteem.

PURPOSE: To evaluate whether contact lens (CL) use was associated with self-esteem in myopic children originally enrolled in the Correction of Myopia Evaluation Trial (COMET), that after 5 years continued as an observational study of myopia progression with CL use permitted. METHODS: Usable data at the 6-year visit, one year after CL use was allowed (n = 423/469, age 12-17 years), included questions on CL use, refractive error measurements and self-reported self-esteem in several areas (scholastic/athletic competence, physical appearance, social acceptance, behavioural conduct and global self-worth). Self-esteem, scored from 1 (low) to 4 (high), was measured by the Self-Perception Profile for Children in participants under 14 years or the Self-Perception Profile for Adolescents, in those 14 years and older. Multiple regression analyses were used to evaluate associations between self-esteem and relevant factors identified by univariate analyses (e.g., CL use, gender, ethnicity), while adjusting for baseline self-esteem prior to CL use. RESULTS: Mean (±S.D.) self-esteem scores at the 6-year visit (mean age = 15.3 ± 1.3 years; mean refractive error = -4.6 ± 1.5 D) ranged from 2.74 (± 0.76) on athletic competence to 3.33 (± 0.53) on global self-worth. CL wearers (n = 224) compared to eyeglass wearers (n = 199) were more likely to be female (p < 0.0001). Those who chose to wear CLs had higher social acceptance, athletic competence and behavioural conduct scores (p < 0.05) at baseline compared to eyeglass users. CL users continued to report higher social acceptance scores at the 6-year visit (p = 0.03), after adjusting for baseline scores and other covariates. Ethnicity was also independently associated with social acceptance in the multivariable analyses (p = 0.011); African-Americans had higher scores than Asians, Whites and Hispanics. Age and refractive error were not associated with self-esteem or CL use. CONCLUSIONS: COMET participants who chose to wear CLs after 5 years of eyeglass use had higher self-esteem compared to those who remained in glasses both preceding and following CL use. This suggests that self-esteem may influence the decision to wear CLs and that CLs in turn are associated with higher self-esteem in individuals most likely to wear them.

Association of education and occupation with myopia in COMET parents.

PURPOSE: To investigate refractive error, especially myopia, in parents of myopic children and its association with education and occupation. METHODS: Six hundred twenty-seven parents (n = 375 mothers and 252 fathers) of the 469 myopic 6- to <12-year-old children enrolled in COMET provided refraction data as well as answered questions about their education and occupation. Eighty-five percent of the refractions were obtained by non-cycloplegic autorefraction (Nidek ARK 700A), and 15% were obtained from the most recent prescription. RESULTS: The mean age ± SD of the parents was 44.26 ± 5.81 years, and their mean spherical equivalent refraction was -2.34 ± 2.94 D. Parents with higher education (college degree or greater) had significantly more myopia (-2.97 ± 2.98 D) than parents with lower education (-1.72 ± 2.76 D). The odds of being myopic were significantly higher in the higher education group (multivariate odds ratio = 2.12, 95% confidence interval = 1.41 to 3.19). Mean myopia also differed significantly by occupation, with parents in white collar jobs (-2.87 ± 3.10 D) significantly more myopic than those in blue collar jobs (-1.21 ± 2.02 D) by 1.66 D (p < 0.001). The odds of being myopic between the two occupation groups were of borderline significance (multivariate odds ratio = 1.61, 95% confidence interval = 0.999 to 2.60). CONCLUSIONS: The parents of myopic children participating in a clinical trial of lenses to slow the progression of myopia had a high prevalence of myopia that was associated with their level of education and to a lesser extent with their choice of occupation. To our knowledge, this is the first account of refractive errors, education, and occupation in parents of a large group of myopic children.

Myopia Progression in Children Wearing Spectacles vs. Switching to Contact Lenses.

PURPOSE: To investigate myopia progression in Correction of Myopia Evaluation Trial (COMET) participants who switched to soft contact lenses (CLs) vs. remained in spectacles after the clinical trial ended. METHODS: Four hundred sixty-nine ethnically diverse, 6- to 11-year-old myopic children were randomly assigned to wear single vision lenses (SVLs) or progressive addition spectacle lenses (PALs) for 5 years as part of COMET. Afterwards they could choose another lens type, including CLs. Data in this article are from 286 participants who wore their original spectacle lenses for 6 years (n = 199) or wore CLs most or all the time between the 5- and 6-year visits (n = 87). Refractive error and axial length (AL) were measured after cycloplegia with 1% Tropicamide. The primary outcome was myopia progression between the 5- and 6-year visits. Two-year myopia progression was evaluated in a subset of 183 participants who wore the same lens type for an additional year. Myopia progression and AL were compared between the two lens groups using multiple linear regression. RESULTS: Participants in the two groups were similar with respect to age, ethnicity, myopia at 5-years, accommodation and phoria, but more girls switched to CLs than remained in spectacles (p < 0.0001). Mean (+/-SD) myopia progression was higher (p = 0.003) after 1 year in the CL group[-0.28+/- 0.33 diopter (D)] than the spectacle group (-0.14+/- 0.36 D), and remained higher after 2 years in the 2-year subset (-0.52+/- 0.46 D vs.-0.25+/- 0.39 D, p < 0.0001). Results were similar after adjustment for related factors. No significant differences in AL were found between groups after adjustment. Corneal curvature remained unchanged in both groups. CONCLUSIONS: COMET children switching from glasses to CLs experienced a small, statistically significant but clinically inconsequential increase in myopia progression.

Evaluating masking in a randomized, double-masked clinical trial in children with myopia.

PURPOSES: The purposes of this study were to evaluate the success of masking in the Correction of Myopia Evaluation Trial (COMET), a study designed as a randomized, double-masked clinical trial comparing the effect of progressive addition lenses (PALs) with single-vision lenses (SVLs) in slowing myopia progression among children and to investigate the impact of unmasking on the treatment effect. METHODS: The success of masking of children and parents was assessed by questionnaires administered after the clinical trial results were reported and before families were informed of their child's lens assignment. Children and parents who correctly guessed their assignment with absolute or "pretty sure" certainty were considered as unmasked. The role of children's age, gender, and ethnicity in unmasking was evaluated using logistic regression. The impact of unmasking on the treatment effect at 3 years was investigated using analysis of variance. The success of masking of the study optometrists was assessed by data collected at the child's follow-up visits. RESULTS: Overall 93% (436 of 469) of the COMET children responded to the questions about lens assignment and certainty. Thirty-seven percent (163 of 436) of children met the criteria for being unmasked with similar results from the parents. The majority (91%) of the 163 "unmasked" children reported that their glasses were the main reason for lens identification. Although children 10 to 11 years at baseline became unmasked more often than did children 6 to 9 years (44% vs. 31%, p = 0.01), there was no difference between boys and girls becoming unmasked (p = 0.2). The treatment effect did not differ between the masked and unmasked children (p = 0.69). The study optometrists became unmasked for five children over the course of 3-year follow up. CONCLUSIONS: Masking was successfully maintained for the study optometrists and the majority (63%) of COMET children. Although some children were able to identify their lens assignment, the primary study outcome was not affected by unmasking.

Reasons for high retention in pediatric clinical trials: comparison of participant and staff responses in the Correction of Myopia Evaluation Trial.

BACKGROUND: The Correction of Myopia Evaluation Trial (COMET), a randomized, multicenter clinical trial of myopia progression in children, had an exceptionally high retention rate of 98.5% (462/469) at three years of follow-up. The present investigation was designed to evaluate and compare the reasons for COMET's high retention rate according to participating families and clinical center staff. METHODS: Families (n = 411) and staff (n = 35) completed a confidential 19-item questionnaire by indicating families' levels of preference for each item, and rating its importance in keeping families in the study. The questionnaire evaluated study features in four categories: staff characteristics, operational aspects, specific study elements, and incentives. RESULTS: Results showed that most families viewed the study very favorably. Features that appealed to 90% or more families and promoted continued study participation included staff attributes such as friendliness, responsiveness and encouragement, and aspects pertaining to standard of care such as completeness of eye exam, quality of eye care and free eyeglasses. Compared to families, staff tended to underestimate the importance of the following features for retention: seeing the same staff at each visit, appointment reminders, center location, newsletters, commitment to the study, being part of a nationwide study, length of the study, association with a college of optometry, completeness of eye exam, and eye drops (p < 0.05 by chi-square analyses). However, staff responses also revealed less preferred components of the study protocol (e.g., eye drops), to which families might have been reluctant to respond unfavorably. CONCLUSIONS: Our findings highlight the importance of intangible factors such as staff attributes and participants' study commitment in maintaining high retention rates, and the usefulness of surveying both families and staff.

Distress associated with prenatal screening for fetal abnormality.

A theoretically-based, multivariate approach was used to identify factors associated with emotional distress for pregnant women undergoing maternal serum alpha fetoprotein (MSAFP or AFP) testing, used to detect abnormalities of the fetal brain and spinal cord. Participants were those who received normal results (N = 87). Study results supported the hypothesis that different factors would predict distress before and after testing. Satisfaction with information about testing predicted lower emotional distress early in the testing process; concerns about the child having other medical conditions and low-dispositional optimism predicted distress later. Study findings indicate that even in women who receive normal test results, AFP testing is associated with a modest degree of emotional disturbance which declines, but does not completely abate, after testing.

Evaluating the self-esteem of myopic children over a three-year period: The COMET Experience.

PURPOSE: The purposes of this study were to evaluate self-esteem over 3 years in the 469 myopic children participating in the Correction of Myopia Evaluation Trial (COMET), and to examine its relationship with lens assignment (progressive addition lenses [PALs] vs. single-vision lenses [SVLs]), myopia progression, and several other ocular and demographic characteristics. METHODS: Data collection included refractive error measurements, child-reported visual symptoms, attitude toward glasses, adherence, and self-esteem as measured by the Self-Perception Profile for Children (SPPC). A two-way analysis of variance (treatment group x time) was performed to examine whether PAL and SVL wearers differed in self-esteem over time. Multiple regression analyses were used to evaluate associations between self-esteem at follow-up and relevant factors identified by univariate analyses. RESULTS: Regardless of lens assignment or myopia progression, COMET children reported moderate to high levels of self-esteem at follow-up in the areas of scholastic and athletic competence, physical appearance, social acceptance, behavioral conduct, and global self-worth. Mean scores ranged from 2.87 (+/- 0.68) on athletic competence to 3.40 (+/- 0.56) on global self-worth. Self-esteem changed significantly (p < 0.05) over 3 years in the domains of scholastic competence, social acceptance, and physical appearance. Self-esteem at follow-up was associated with visual symptoms, attitude toward glasses, age, gender, and ethnicity. CONCLUSIONS: Lens assignment and myopia progression were not associated with self-esteem in the COMET cohort. These children had high levels of self-esteem, suggesting that having myopia does not negatively impact self-esteem. Follow-up reports will monitor self-esteem and related factors in this cohort of myopic children over the course of adolescence and early adulthood.

The relationship between self-esteem of myopic children and ocular and demographic characteristics.

PURPOSE: To evaluate self-esteem and its relationship with various ocular and demographic characteristics in 469 myopic children participating in the Correction of Myopia Evaluation Trial (COMET), an ongoing, randomized, multicenter clinical trial designed to evaluate the effects of progressive addition lenses vs. single vision lenses on the progression of juvenile-onset myopia. METHODS: Baseline data collection included demographic information, refractive error measurements, parent-reported myopia history, child-reported visual symptoms, and self-esteem in several areas (scholastic/athletic competence, physical appearance, social acceptance, behavioral conduct, and global self-worth) as measured by the Self-Perception Profile for Children. Univariate and multiple regression analyses were used to identify factors associated with self-esteem. RESULTS: The Self-Perception Profile for Children is a reliable measure of self-esteem in COMET children as indicated by the high internal consistency reliabilities (0.74 to 0.81) obtained for the various domains. COMET children's mean self-esteem scores ranged from 2.72 +/- 0.69 for athletic competence to 3.36 +/- 0.56 for global self-worth and were similar to normative samples. Multiple regression analyses showed that less symptomatic children had higher self-esteem in all areas (p < 0.05), except athletic competence, after adjusting for other ocular and demographic characteristics. Self-esteem also varied significantly by age, gender, and ethnicity (p < 0.05). CONCLUSIONS: Baseline self-esteem is associated with visual symptoms, age, gender, and ethnicity, but not with magnitude of refractive error. Follow-up reports will assess whether there are changes in self-esteem associated with myopia progression and lens assignment.