Intraobserver Repeatability Assessment of the S390L Firefly WDR Slitlamp in Patients With Dry Eye Disease: Objective, Automated, and Noninvasive Measures.

OBJECTIVES: To assess the intraobserver repeatability of automated, objective, and noninvasive measures obtained with the S390L Firefly WDR slitlamp. METHODS: This cross-sectional study included 50 eyes of patients with dry eye disease with a mean age of 55.06±12.96 years. Three consecutively repeated measures of the following variables were obtained: first noninvasive break-up time (F-NIBUT), average noninvasive break-up time (A-NIBUT), tear meniscus height, tear meniscus area (TMA), nasal ciliary hyperemia (NCIH), temporal ciliary hyperemia (TCIH), nasal conjunctival hyperemia (NCOH), temporal conjunctival hyperemia (TCOH), upper loss area meibomian gland (U-LAMG), lower loss area meibomian gland (L-LAMG), upper meibomian gland dysfunction grade (U-MGD grade), and lower meibomian gland dysfunction grade (L-MGD grade). Intraobserver repeatability was estimated with coefficient of variation (CoV), intrasubject standard deviation (SD) (S w ), and Bland-Altman plots. RESULTS: All variables showed no statistically significant differences in the repeated-measures analysis except for L-MGD grade ( P =0.045). F-NIBUT and A-NIBUT obtained the highest CoV with an average value of 0.48±0.41 [0.02-1.00] and 0.34±0.25 [0.02-1.00], respectively. The remaining variables showed CoVs between 0.04±0.11 [0.00-0.43] and 0.18±0.16 [0.00-0.75]. A-NIBUT, TMA, NCOH, and L-LAMG obtained an S w of 2.78s, 0.21 mm 2 , <0.001, and 4.11%, respectively. Bland-Altman plots showed a high level of agreement between pairs of repeated measures. CONCLUSION: The S390L Firefly WDR slitlamp has moderate intraobserver repeatability for F-NIBUT and A-NIBUT, which suggests that F-NIBUT and A-NIBUT are tests with high variability. The remaining variables show satisfactory intraobserver repeatability.

Binocular and accommodative function in the controlled randomized clinical trial MiSight® Assessment Study Spain (MASS).

PURPOSE: To evaluate the binocular and accommodative function in children wearing dual focus (DF) MiSight® contact lenses (CLs) for myopia control compared with children wearing single-vision (SV) spectacles. METHODS: This was a randomized, controlled clinical trial involving subjects aged 8 to 12, with myopia ranging from - 0.75 to - 4.00D and astigmatism < 1.00D, allocated to MiSight® study CLs group or control group wearing SV. Binocular and accommodative function was determined at baseline, 12-, and 24-month visits, assessed by the following sequence of tests: distance and near horizontal phoria, accommodative convergence/accommodation (AC/A) ratio, stereopsis, accommodative amplitude (AA), and accommodative response (AR) at 33, 25 and 20 cm. RESULTS: Seventy-four children completed the study: 41 in the CL group and 33 in the SV group. CLs group did not show any significant differences in binocular and accommodative measurements throughout the study. In control group, distance and near phoria, stereopsis, AC/A and AR at 20 cm did not show any significant change, but AA, AR at 33 cm and AR at 25 cm were greater at 24-month visit compared with baseline (p < 0.05). CONCLUSIONS: DF lenses do not change the binocular and accommodative function in children wearing dual focus CLs. TRIAL REGISTRATION: NCT01917110.

MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and Discontinuations.

OBJECTIVES: To assess the relative clinical success of MiSight contact lenses (CLs) (study group) and distance single-vision (SV) spectacles (control group) in children in terms of adverse events (AEs), discontinuations, and tear film osmolarity over a 2-year period. METHODS: Seventy-four subjects aged 8 to 12 with myopia of -0.75 to -4.00 D and astigmatism less than 1.00 D were randomly assigned to MiSight CLs or SV groups. Subjects were monitored at 6-month intervals over the course of 24 months and advised to report to the clinic immediately should AEs occur. Adverse events were categorized as serious, significant, and nonsignificant. Discontinuation was defined as cessation of participation in the study. RESULTS: Forty-four children were corrected with MiSight CLs and 33 with SV spectacles. No serious or significant AEs were found in any of the participants in either group. Two nonsignificant AEs were found in MiSight group, corresponding to a foreign body on the cornea in two children. There were five discontinuations in MiSight group, one because of change of residence and four because of unwillingness to use the CL. There were no discontinuations in SV group. Neither group showed any significant changes in osmolarity data over the 24 months of follow-up (P≥0.05). CONCLUSIONS: No clinically serious events were observed in either group. Our results show that correct use of MiSight CLs is a safe option for myopia correction. The success of this treatment requires a combination of proper lens fitting, good adherence to routine follow-ups, and timely treatment of complications.

MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial.

PURPOSE: To compare myopia progression in children randomized to MiSight contact lenses (CLs) versus children corrected with single-vision spectacles (SV) over a 2-year period. METHODS: Subjects aged 8 to 12 with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were assigned to the lens study group (MiSight) or the control group (single vision). Measurements of visual acuity and subjective refraction were taken at 6-month intervals, and axial length, anterior chamber, corneal power, and cycloplegic autorefraction were measured at the baseline, 12-month, and 24-month visits. RESULTS: Eighty-nine subjects were recruited. Forty-fix children were assigned to the MiSight group, and 33 to the single-vision spectacle group. In total, 74 children completed the clinical trial, with the following parameters at the beginning of the study: n = 41 in the MiSight group (age: 11.01 ± 1.23 years, spherical equivalent: -2.16 ± 0.94 D, gender: male: 21, female: 20) and n = 33 in the single-vision group (age: 10.12 ± 1.38 years, spherical equivalent: -1.75 ± 0.94 D, gender: male: 12, female: 21). After 2 years of follow-up, myopia progressed slowly in the MiSight group compared to the control group (0.45 D vs 0.74 D, p < 0.001) and there was less axial elongation in the MiSight group compared to the single-vision group (0.28 mm vs 0.44 mm, p < 0.001). Therefore, use of MiSight CLs produced lower myopia progression (39.32%) and lower axial growth of the eye (36.04%) at 2 years compared to spectacle use. CONCLUSIONS: MiSight contact lens wear reduces axial elongation and myopia progression in comparison to distance single-vision spectacles in children. ClinicalTrials.gov Identifier: NCT01917110.

MiSight Assessment Study Spain: A Comparison of Vision-Related Quality-of-Life Measures Between MiSight Contact Lenses and Single-Vision Spectacles.

OBJECTIVES: Recent research has shown that concentric contact lenses (CLs) can be a way to control the progression of myopia. The purpose of the current study was to compare vision-related quality-of-life measures in children wearing distance single-vision (SV) spectacles versus MiSight CLs, a specific concentric design for myopia control. METHODS: Subjects aged 8 to 12 with myopia from -0.75 to -4.00 diopters (D) of sphere and astigmatism less than 1.00 D of cylinder were allocated to the lenses study group (MiSight) or control group (SV). A Pediatric Refractive Error Profile (PREP) questionnaire was administered at 12- and 24-month intervals to evaluate children's perceptions in overall vision, near vision, far distance vision, symptoms, appearance, satisfaction, activities, academic performance, handling, and peer perceptions. The mean score of all items was calculated as the overall score. RESULTS: In total, 74 children completed the study: n=41 in the MiSight group and n=33 in the SV group. In the MiSight group, the ratings at 12 and 24 months for appearance, satisfaction, effect on activities, handling, and peer perceptions were significantly better than those given by children in the SV group (P<0.001), as was the overall score. However, near vision was significantly better in the SV group at both 12 and 24 months (P<0.001). CONCLUSIONS: MiSight CL wear for controlling myopia improves vision-related quality of life in children when compared with spectacle wear.