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Status unknownNCT02722291Updated Apr 1, 2016

Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

An interventional study of Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.) in Pinhole, sponsored by Chung-Ang University Hosptial, Chung-Ang University College of Medicine. Status unknown at 1 site in Korea, Republic of. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-01.

Sponsored by Chung-Ang University Hosptial, Chung-Ang University College of Medicine · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
45 Years and older
Sex
All
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Study summary

This study is aimed at presbyopic patients that do not require magnifying glass at close rage. The purpose of this study is to investigate the functional and physiological changes in eye induced by pinhole glass.

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Conditions studied

  • Pinhole

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Keywords

  • presbyopia
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In context

Presbyopia

324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.

This study's planned enrollment of 40 is below the median of 61 across 265 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. age over 45 years
  2. spherical equivalents(SE) within ± 3.0 diopters(D)
  3. normal ocular alignment

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    presbyopia

    All participants perform all exams under 3 conditions, that is baseline, with out pinhole glasses, and with multiple pinhole glasses

    Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)

Interventions

  • DeviceTrayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)
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What researchers measure

Primary outcomes

  1. Distant visual acuity (logMAR)

    Distant visual acuity were measured using Snellen chart (Precision Vision, La Salle, IL, USA) at 4 m.

    Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study

  2. BUT

    fluorescein is instilled into the subject's tear film and the subject is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination

    Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study

  3. Near point of accommodation (NPA)

    Near point of accommodation (NPA) was measured using Donder's push-up method.

    Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study

  4. The fusional convergence

    With the subject watching the 20/30 sized fixation target at 40 cm, we take the base-out bar prism on the subject's right eye. While gradually increasing the extent of the prism, the first point that the subject noticed diplopia was defined as the break point.

    Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study

  5. Stereopsis

    Stereopsis was checked with the Randot Stereotest (Stereo Optical Co., Chicago, IL, USA).

    Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study

  6. 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.

    Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study

  7. Photopic pupil size (baseline, mm)

    Pupil size under photopic conditions (85 cd/m2) was measured using a WASCA Analyzer (Carl Zeiss Meditec, Oberkochen, Germany).

    Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study

  8. Pupil size with the one eye pinhole glasses (mm)

    Pupil size with the one eye pinhole glasses was measured using a WASCA Analyzer (Carl Zeiss Meditec, Oberkochen, Germany).

    Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study

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Study locations

1 of 1 sites recruiting
  • Chung-Ang University Hospital
    Seoul, 156-755, Korea, Republic of
    Recruiting
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References and documents

Publications

  • Park HH, Park IK, Moon NJ, Chun YS. Clinical feasibility of pinhole glasses in presbyopia. Eur J Ophthalmol. 2019 Mar;29(2):133-140. doi: 10.1177/1120672118810999. Epub 2018 Nov 21. PubMed 30460857 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02722291
Lead sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Responsible party
Hong Hyun Park (Principal investigator, Chung-Ang University Hosptial, Chung-Ang University College of Medicine) — Principal investigator
First posted
Mar 30, 2016
Start date
Mar 2016
Primary completion
Dec 2016 (estimated)
Completion
Mar 2017 (estimated)
Last update
Apr 1, 2016
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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