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

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ClinicalTrials.gov Identifier: NCT02572544
Recruitment Status : Unknown
Verified October 2015 by WonSoo Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine.
Recruitment status was:  Recruiting
First Posted : October 9, 2015
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
WonSoo Kim, 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.

Condition or disease Intervention/treatment Phase
Functional Vision Changes Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : October 2015
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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




Primary Outcome Measures :
  1. Distant visual acuity (logMAR) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572544


Contacts
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Contact: WonSoo Kim, MD +82-2-6299-1666 onewat5@hotmail.com

Locations
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Korea, Republic of
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 156-755
Contact: WonSoo Kim, MD    +82-2-6299-1666    onewat5@hotmail.com   
Sponsors and Collaborators
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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: October 9, 2015    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2015
Keywords provided by WonSoo Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine:
young healthy adults
single pinhole glasses
multiple pinhole glasses