Accommodative Behaviors in Multifocal Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm)
研究概览
简要总结
Addition lenses are often used to treat a range of eye conditions. Addition lenses are specifically used to help patients who do not have the ability to focus their eyes to see clearly up close. Eye focusing is called accommodation. Addition lenses are easy to prescribe in a pair of glasses and are often called the bifocal portion of the glasses. Addition lenses can be used for adults who have presbyopia (they cannot read up close without the aide of a bifocal) and for patients of all ages who have eye focusing problems (e.g. accommodative insufficiency, accommodative infacility, accommodative dysfunction).
Addition powers can also be put into contact lenses. Contact lenses that have addition powers in them are called multifocal contact lenses. These are often marketed for patients that are 40 and over who have presbyopia, and are prescribed to help patients see up close as well as far away in their contact lenses. Multifocal contact lenses are also used in children with nearsightedness because studies have shown that some multifocal designs can slow down the progression of nearsightedness. As stated before, addition lenses can be used to treat eye focusing problems in patients of all ages, before presbyopia. What is unclear is whether the addition power in contact lenses has the same treatment effect as an addition power in a pair of glasses when they are being used to treat eye focusing problems. This study will assess how different kinds of multifocal contact lenses (center distance or center near) will change eye focusing and eye teaming in young adult patients.
详细描述
Soft multifocal contact lenses are used for a variety of reasons in patient care. In fact, studies have shown that soft multifocal contact lenses alter accommodation. While most often used to correct presbyopic vision, these lenses are also used in the management of accommodative and binocular vision disorders along with myopia management. Multifocal contact lenses correct vision at different distances by introducing a power gradient over the eye thus providing a range of clear vision at both distance and near.
For center near designs, the near addition is placed in the center of the lens, and the power becomes more negative in the periphery. Generally, it is thought that center near designs provide the most accommodative relief and superior near vision because the near addition is centered in the pupil. These lenses allow maximum near correction, even with miotic pupil size changes associated with accommodation. Conversely, for center distance designs, the distance prescription is placed in the center, and the power of the lens becomes more positive in the periphery to provide the near addition. To date, most studies have used center-distance lens designs to evaluate accommodative ability and function. Accommodative function while wearing center near lenses has likely not been studied often because these lens designs are used most in populations with no or waning accommodative ability (i.e. presbyopic patients). In this population lenses are used, specifically, to account for that accommodative inability.
Center near and distance designs have varying advantages and disadvantages for presbyopic vision correction. Selection of lens design can be based on a patient's individual visual needs. There is conflicting evidence on whether the add power in soft multifocal contact lenses can be used to manage accommodative and binocular vision disorders. These lenses do offer relief of accommodative demand associated with both accommodative and binocular vision disorders. It has been hypothesized that center near multifocal contact lenses provide a greater therapeutic effect as the central portion of the lens is the addition power. There have been case reports demonstrating benefits of multifocal contact lenses in accommodative insufficiency and convergence excess. Center distance lenses are used most often for myopia management. In these situations, the interest has been to determine if the child can maintain normal accommodative function while wearing the lenses. This study will aim to determine how accommodative function varies with center distance and center near multifocal contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not know what lens they are in
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18 to ≤ 30 years old
- •Acuity of 20/25 or better in both eyes with habitual contact lens prescription
- •No history of ocular disease or active ocular inflammation
- •No history of ocular or refractive surgery
- •No current history of rigid contact lens wear
- •Astigmatism ≤1.00 D
- •Free of binocular vision disorder (strabismus, amblyopia, vergence dysfunction, accommodative dysfunction)
排除标准
- •No prior or concurrent participation in myopia control or use of low dose atropine, multifocal contact lenses
- •No use of any medications suspected to affect accommodation
结局指标
主要结局
Objective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm)
时间窗: Up to two hours (1 hour in each lens)
Accommodative function will be compared using the Grand Seiko Autorefractor between the center distance and center near group. The instrument will record the patient's refractive error at near (40 cm), which is commonly used for near assessment in clinic. Patients place their head on a chin rest and look at targets at different distances. The examiner then pushes a button and the refractive error (in Diopters) is recorded from the instrument and placed in an excel file to be analyzed.
Objective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm)
时间窗: Up to two hours (1 hour in each lens)
Accommodative function will be compared using the Grand Seiko Autorefractor between the center distance and center near group. The instrument will record the patient's refractive error at near (40 cm), which is commonly used for near assessment in clinic. Patients place their head on a chin rest and look at targets at different distances. The examiner then pushes a button and the refractive error (in Diopters) is recorded from the instrument and placed in an excel file to be analyzed.
次要结局
- Accommodation (in Diopters) Measured by Monocular Push-Up(Up to 2 hours)
- Accommodation (in Cycles Per Minute) Measured by Accommodative Facility(Up to 2 hours)
- Phoria (in Prism Diopters) Measured by Modified Thorington at Distance(Up to 2 Hours)
- Accommodation (in Diopters) Measured by Monocular Estimation Method (MEM)(Up to two hours)
- Accommodation (in Diopters) Measured by Monocular Push-Up(Up to 2 hours)
- Accommodation (in Cycles Per Minute) Measured by Accommodative Facility(Up to 2 hours)
- Phoria (in Prism Diopters) Measured by Modified Thorington at Distance(Up to 2 Hours)
- Phoria (in Prism Diopters) Measured by Modified Thorington at Near(Up to 2 hours)
研究者
Ann Morrison
Assistant Professor
Ohio State University
