Comparison of Objective and Subjective Changes Induced by Multiple Pinhole Glasses and Single Pinhole Glasses

Not Applicable

• Conditions: Functional Vision Changes
• Interventions: Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)

• Registration Number: NCT02572544
• Lead Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Primary Completion: 2015-10
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-08
• Last Update Submitted: 2015-10-08
• Study First Posted: 2015-10-09
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. age between 20 and 45 years;
2. spherical equivalents (SE) within ± 6.0 diopters (D);
3. correctable distant and near visual acuity by glasses up to 20/20;
4. normal intraocular pressure with normal optic disc appearance;
5. normal ocular alignment.

Exclusion Criteria

1. 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;
2. corneal pathologic features;
3. glaucoma;
4. cataracts of grade II or greater by the Lens Opacities Classification System III (LOCS III);
5. vitreous and retinal abnormalities that might limit the accuracy of testing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)	All participants perform all exams under 3 conditions, that is baseline, single pinhole glasses, and multiple pinhole glasses

Primary Outcome Measures

Name	Time	Method
Depth of focus	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)	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)	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	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)	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)	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)	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)	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	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)	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.

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of