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

Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT02572544
Collaborator
(none)
30
1
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Oct 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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).

  8. 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).

  9. 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.

  10. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chung-Ang University Hospital Seoul Korea, Republic of 156-755

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
WonSoo Kim, Department of Ophthalmology, Chung-Ang University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
ClinicalTrials.gov Identifier:
NCT02572544
Other Study ID Numbers:
  • ChungAngUHeye
First Posted:
Oct 9, 2015
Last Update Posted:
Oct 9, 2015
Last Verified:
Oct 1, 2015
Keywords provided by WonSoo Kim, Department of Ophthalmology, Chung-Ang University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study Results

No Results Posted as of Oct 9, 2015