Comparison of Objective and Subjective Changes Induced by Multiple Pinhole Glasses and Single Pinhole Glasses
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Depth of focus
研究概览
简要总结
Purpose of this study is to compare the ocular functional changes including pupil size, visual acuity, depth of focus, accommodative amplitude, visual field, contrast sensitivity, and stereopsis induced by multiple and single pinhole glasses, in addition, to check reading speed and survey for ocular discomfort after using both pinhole glasses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 20 and 45 years;
- •spherical equivalents (SE) within ± 6.0 diopters (D);
- •correctable distant and near visual acuity by glasses up to 20/20;
- •normal intraocular pressure with normal optic disc appearance;
- •normal ocular alignment.
排除标准
- •disturbance of accommodation due to any reasons such as an Adie's pupil, Parkinson's disease, a history of previous ocular surgery or trauma, and a history of systemic or topical medication that might affect accommodation;
- •corneal pathologic features;
- •cataracts of grade II or greater by the Lens Opacities Classification System III (LOCS III);
- •vitreous and retinal abnormalities that might limit the accuracy of testing.
研究组 & 干预措施
Participants
All participants perform all exams under 3 conditions, that is baseline, single pinhole glasses, and multiple pinhole glasses
干预措施: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.) (Device)
结局指标
主要结局
Depth of focus
时间窗: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Monocular DOF was checked with a 4-m Snellen chart under distance correction without cycloplegics.
Distant visual acuity (logMAR)
时间窗: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Distant visual acuity were measured using Snellen chart (Precision Vision, La Salle, IL, USA) at 4 m.
Accommodative amplitude (Diopter)
时间窗: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Near point of accommodation (NPA) was measured using Donder's push-up method.
Contrast sensitivity
时间窗: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Monocular contrast sensitivity test was performed using a CSV-1000E Contrast Testing Instrument (VectorVision, Dayton, OH, USA) at 2.5-m distance under standard brightness (85 cd/m2)
Photopic pupil size (baseline, mm)
时间窗: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Pupil size under photopic conditions (85 cd/m2) was measured using a WASCA Analyzer (Carl Zeiss Meditec, Oberkochen, Germany).
Reading speed (letters per second)
时间窗: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Reading speed was evaluated using the famous Korean traditional fairy tale book. This Korean book was printed black-and-white with 10-font size. The time taken to read designated 10 pages including 3985 letters was recorded, and then reading speed was calculated as letters per second (LPS).
Near visual acuity (logMAR)
时间窗: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Near visual acuity using Logarithmic Visual Acuity Chart 2000 (Precision Vision, La Salle, IL, USA) at 40 cm.
Stereopsis (seconds of arc)
时间窗: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Stereopsis was checked with the Randot Stereotest (Stereo Optical Co., Chicago, IL, USA).
Standard automated perimetry
时间窗: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Visual field (VF) test was performed with a Humphrey Visual Field Analyzer (Carl Zeiss Meditec, Inc., Dublin, CA, USA) using the 30-2 Swedish interactive threshold algorithm.
Pupil size with the both pinhole glasses (mm)
时间窗: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Pupil size with the both pinhole glasses using the ruler attached to the lateral rim of the glasses.
次要结局
未报告次要终点
研究者
WonSoo Kim
Department of Ophthalmology, Chung-Ang University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine