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

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.

Study Overview

• Status: Unknown
• Conditions: Functional Vision Changes
• Intervention / Treatment: Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-755
    • Recruiting
    • Chung-Ang University Hospital
    • Contact: WonSoo Kim, MD; Phone Number: +82-2-6299-1666; Email: onewat5@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants; All participants perform all exams under 3 conditions, that is baseline, single pinhole glasses, and multiple pinhole glasses	Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.); Wearing multiple and single pinhole glasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant visual acuity (logMAR)	Distant visual acuity were measured using Snellen chart (Precision Vision, La Salle, IL, USA) at 4 m.	Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Photopic pupil size (baseline, mm)	Pupil size under photopic conditions (85 cd/m2) was measured using a WASCA Analyzer (Carl Zeiss Meditec, Oberkochen, Germany).	Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Depth of focus	Monocular DOF was checked with a 4-m Snellen chart under distance correction without cycloplegics.	Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Accommodative amplitude (Diopter)	Near point of accommodation (NPA) was measured using Donder's push-up method.	Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Standard automated perimetry	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.	Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Contrast sensitivity	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)	Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Stereopsis (seconds of arc)	Stereopsis was checked with the Randot Stereotest (Stereo Optical Co., Chicago, IL, USA).	Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Reading speed (letters per second)	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).	Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Near visual acuity (logMAR)	Near visual acuity using Logarithmic Visual Acuity Chart 2000 (Precision Vision, La Salle, IL, USA) at 40 cm.	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 (mm)	Pupil size with the both pinhole glasses using the ruler attached to the lateral rim of the glasses.	Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.

Collaborators and Investigators

• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Publications and helpful links

General Publications

• Kim WS, Park IK, Park YK, Chun YS. Comparison of Objective and Subjective Changes Induced by Multiple-Pinhole Glasses and Single-Pinhole Glasses. J Korean Med Sci. 2017 May;32(5):850-857. doi: 10.3346/jkms.2017.32.5.850.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Estimate): October 9, 2015
• Last Update Submitted That Met QC Criteria: October 8, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: young healthy adults; single pinhole glasses; multiple pinhole glasses
• Other Study ID Numbers: ChungAngUHeye