Dataset Information

Study of Theories about Myopia Progression (STAMP) design and baseline data.

ABSTRACT: The Study of Theories about Myopia Progression (STAMP) is a 2-year, double-masked, randomized clinical trial of myopic children 6 to 11 years of age. STAMP will evaluate the 1-year effect of progressive addition lenses (PALs) compared with single vision lenses (SVLs) on central refraction, peripheral refraction in four quadrants, and accommodative response and convergence. STAMP will also evaluate any changes 1 year after discontinuing PALs. Baseline characteristics of enrolled children are reported.Eligible children had a high accommodative lag and either low myopia (less myopic than -2.25 diopter (D) spherical equivalent) or high myopia (more myopic than -2.25 D spherical equivalent) and esophoria at near. Children were randomly assigned to wear either PALs or SVLs for 1 year to determine the difference in myopia progression in the PAL group relative to the SVL group. All children will then wear SVLs for the 2nd year to evaluate the permanence of any treatment effect. Complete ocular biometric data are collected at 6-month intervals.Over 17 months, 192 children were screened, and 85 (44%) were eligible and enrolled. Of these 85 children, 44 (52%) were girls, and 54 (64%) were esophoric at near. The mean age (± SD) was 9.8 ± 1.3 years. The right eye mean cycloplegic spherical equivalent refractive error was -1.95 ± 0.78 D. Horizontal relative peripheral hyperopia (30° nasal retina + 0.56 ± 0.59 D; 30° temporal retina + 0.61 ± 0.77 D) and vertical relative peripheral myopia (30° superior retina -0.36 ± 0.92 D; 20° inferior retina -0.48 ± 0.83 D) were found.The baseline data for STAMP are reported. Asymmetry between vertical and horizontal meridian relative peripheral refraction was found. STAMP will use the ocular biometric changes associated with the PAL treatment effect to attempt to elucidate the mechanism responsible for the treatment effect.

SUBMITTER: Berntsen DA

PROVIDER: S-EPMC3075061 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Study of Theories about Myopia Progression (STAMP) design and baseline data.

Berntsen David A DA Mutti Donald O DO Zadnik Karla K

Optometry and vision science : official publication of the American Academy of Optometry 20101101 11

<h4>Purpose</h4>The Study of Theories about Myopia Progression (STAMP) is a 2-year, double-masked, randomized clinical trial of myopic children 6 to 11 years of age. STAMP will evaluate the 1-year effect of progressive addition lenses (PALs) compared with single vision lenses (SVLs) on central refraction, peripheral refraction in four quadrants, and accommodative response and convergence. STAMP will also evaluate any changes 1 year after discontinuing PALs. Baseline characteristics of enrolled c ...[more]

PMID: 20935586

Similar Datasets

Project description:SIGNIFICANCE:The Bifocal & Atropine in Myopia (BAM) study aims to determine whether combining 0.01% atropine and +2.50-diopter add center-distance soft bifocal contact lenses (SBCL) slows myopia progression more than SBCL alone. The results could provide significant information on the myopia control effect of combining optical and pharmacological treatments. PURPOSE:This article describes the subject characteristics at baseline, the study methods, and the short-term effects of this combination treatment on visual acuity (VA) and vision-related outcomes. METHODS:Subjects from the BAM study who met the baseline eligibility criteria were dispensed the combination treatment for 2 weeks to determine final eligibility. Outcome measures included VA at near and distance (Bailey-Lovie logMAR charts), near phoria (modified Thorington), accommodative lag (Grand Seiko WAM-5500), and pupil size (NeurOptics VIP-200 Pupillometer). Compliance was monitored using surveys. Two subgroups in the Bifocal Lenses In Nearsighted Kids study, single-vision contact lens wearers and those who wore +2.50-diopter add SBCL, will serve as the age-matched historical controls for BAM study. RESULTS:Forty-nine BAM subjects (9.6 ± 1.4 years) were enrolled; mean spherical equivalent cycloplegic autorefraction was -2.33 ± 1.03 diopters. After 2 weeks of treatment, the best-corrected low-contrast (10% Michelson) distance VA was reduced (pre-treatment, +0.09 ± 0.07; post-treatment, +0.16 ± 0.08; P < .0001), but the high-contrast VA at near or distance was unaffected. Near phoria increased by approximately 2 in the exo direction (P = .01), but the accommodative lag was unchanged. The pupil size was not significantly different between pre-treatment and post-treatment of either the photopic or mesopic condition. Surveys indicated that the subjects wore SBCL 77 ± 22% of waking hours and used atropine 6.4 ± 0.7 days per week. CONCLUSIONS:Two weeks of combination treatment reduced low-contrast distance VA and increased near exophoria slightly, but the subjects were compliant and tolerated the treatment well.

Project description:The Multidomain Alzheimer Preventive Trial (MAPT study) was designed to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multidomain intervention (consisting of nutritional counseling, physical exercise, cognitive stimulation) or a combination of the two interventions on the change of cognitive functions in frail subjects aged 70 years and older for a period of 3 years. Ancillary neuroimaging studies were additionally implemented to evaluate the impact of interventions on cerebral metabolism (FDG PET scans) and atrophy rate (MRIs), as well as brain amyloïd deposit (AV45 PET scans).1680 subjects (mean age: 75.3 years; female: 64.8 %), enrolled by 13 memory clinics, were randomized into one of the following four groups: omega-3 supplementation alone, multidomain intervention alone, omega-3 plus multidomain intervention, or placebo. Participants underwent cognitive, functional and biological assessments at M6, M12, M24 and M36 visits. The primary endpoint is a change of memory function at 3 years, as assessed by the Free and Cued Selective Reminding test. All participants will be followed for 2 additional years after the 3-years intervention (MAPT PLUS extension study).1/Omega-3 supplementation: two soft capsules daily as a single dose, containing a total of 400 mg docosahexaenoic acid (DHA), i.e., 800 mg docosahexaenoic acid per day, for 3 years. 2/ Multidomain intervention: collective training sessions conducted in small groups (6-8 participants) in twelve 120-minute sessions over the first 2 months (two sessions a week for the first month, and one session a week the second month) then a 60-minute session per month in the following three areas: nutrition, physical activity, and cognition until the end of the 3 years. In addition to the collective sessions, individualized preventive outpatient visits exploring possible risk factors for cognitive decline are performed at baseline, M12 and M24.For cognition, the mean MMSE at baseline was 28.1 (± 1.6). About 58% and 42% of participants had a CDR score equal to 0 and 0.5, respectively. Regarding mobility status, 200 (11.9%) had a 4-m gait speed lower or equal to 0.8 m/s. According to the Fried criteria, 673 (42.1%) participants were considered pre frail, and 51 (3.2%) frail. The red blood cell DHA content was 26.1 ± 8.1 µg/g. Five hundred and three participants underwent baseline MRI. AV45 PET scans were performed in 271 individuals and preliminary results showed that 38.0% had a cortical SUVR > 1.17, which gave an indication of significant brain amyloïd deposit. DISCUSSION: The MAPT trial is presently the first largest and longest multidomain preventive trial relevant to cognitive decline in older adults with subjective memory complaints. The multidomain intervention designed for the MAPT trial is likely to be easily implemented within the general population.

Project description:The aim of this research is to initiate a 5-year natural history study of dry eye disease (DED) using objectively assessed and patient-reported outcomes, to explore the hypothesis that DED is a progressive condition that has substantive and measurable impacts not only on the ocular surface, but on quality of life and visual functioning. Our objective for this report is to examine the baseline data.A multicenter, prospective, controlled, observational study of Level 2 (mild-to-moderate) DED patients based on International Task Force Delphi Panel severity grading, and controls, documented baseline measures (including tear film biomarkers and quality of life). Tear cytokine concentrations were also measured in the tear film. Patients were using artificial tears as needed.Two hundred seventeen DED patients and 67 gender- and age-matched controls were enrolled. A majority were females and Caucasian and groups did not differ significantly in terms of gender, race, or age. Differences between DED and matched controls, at baseline, included mean scores for Ocular Surface Disease Index (31.7 vs 4.1, P?<?0.0001), Schirmer test (5.7 vs 15.3 mm, P?<?0.0001), corneal staining (1.4 vs 0.2, P?<?0.0001), conjunctival staining (1.4 vs 0.3, P?<?0.0001), and tear break-up time (5.7 vs 8.5 s, P?<?0.0001). Tear cytokines levels were determined and included interferon-?, interleukin (IL)-1?, IL-2, IL-4, IL-6, IL-8, tumor necrosis factor-?, epidermal growth factor, IL-13, IL-17, IL-1?, and inducible protein-10. The mean levels of IL-8 and IL-6 were slightly higher in the DED group at baseline. Blurred vision was reported as moderate/severe/very severe at baseline in 57.6% of DED patients vs.10.5% of normal controls (P?<?0.0001). DED patients reported greater reductions in work and non-work productivity, as well as greater need for visits to ophthalmologists during the prior year.In this report of the baseline findings of a 5-year natural history study of DED, a striking disease burden is observed with regard to blurred vision, productivity, and visits to eye care practitioners in mild to moderate DED patients compared to normal subjects of similar ages and genders.ClinicalTrials.gov NCT00833235 on January 30, 2009.

Dataset Information

Study of Theories about Myopia Progression (STAMP) design and baseline data.

Publications

Study of Theories about Myopia Progression (STAMP) design and baseline data.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets