Correction of Hyperopia in Children Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- Change in Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
研究概览
简要总结
The Correction of Hyperopia In Children Study (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle correction for moderate amounts of hyperopia on visual function, attention, and reading skills in children.
详细描述
Hyperopia (farsightedness) has been reported to be associated with reduced visual perceptual and reading abilities. However, there is controversy regarding whether or not to prescribe for low to moderate amounts of hyperopia. The Correction of Hyperopia In Children Study (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle correction for moderate amounts of hyperopia on visual function, attention, and reading skills in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-11 years;
- •At least +1.00D Hyperopia (farsightedness);
- •< +4.00D Hyperopia;
- •< 1.00D Astigmatism;
- •< 1.00D Anisometropia (difference between the two eyes);
- •Willing to be randomized;
- •Best corrected visual acuity of 20/25 or better in each eye;
- •Willing to wear eyeglasses full-time;
- •Willing to return for follow-up visits
排除标准
- •Previous wear of glasses or contacts for farsightedness/hyperopia;
- •Eye disease that affects visual function;
- •Amblyopia (lazy eye);
- •Strabismus (eye turn);
- •History of strabismus surgery;
- •Chronic use of any of the following medications:
- •Antianxiety agents (Librium, Valium)
- •Antiarrythmic agents (Cifenline, Cibenzoline)
- •Anticholinergics (Motion sickness patch - scopolamine)
- •Bladder spasmolytic (Propiverine)
- •Chloroquine
- •Phenothiazines (Compazine, Mellaril, Thorazine)
- •Tricyclic antidepressants (Elavil, Nortriptyline, Tofranil)
结局指标
主要结局
Change in Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
时间窗: 6 week outcome exam
The Kaufman Test of Educational Achievement (K-TEA) was used to measure change in reading skill (reading comprehension). The K-TEA is a well-established, individually administered, standardized test for assessment of achievement in reading, with a mean standard score of 100 and standard deviation of 15. Higher values represent better performance.
次要结局
- Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)(6 week outcome exam)
- Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)(6 week outcome exam)
研究者
Marjean Kulp
Professor
Ohio State University