Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

Study Overview
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Brief Summary
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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.

Conditions
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Pinhole

Intervention / Treatment
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* Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 45 years spherical equivalents(SE) within ± 3.0 diopters(D) normal ocular alignment Exclusion Criteria: 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 corneal pathologic features glaucoma cataracts of grade II or greater by the Lens Opacities Classification System III (LOCS III) vitreous and retinal abnormalities that might limit the accuracy of testing

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: presbyopia<br>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.)<br> <br> |

What is the study measuring?
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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 pinhole and without wearing pinhole with one week apart in random order after baseline study | 
| 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 | Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study | 
| Near point of accommodation (NPA) | Near point of accommodation (NPA) was measured using Donder's push-up method. | Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study | 
| 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. | Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study | 
| Stereopsis | Stereopsis was checked with the Randot Stereotest (Stereo Optical Co., Chicago, IL, USA). | Subjects performed this examination while wearing multiple pinhole and without wearing pinhole 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. | Subjects performed this examination while wearing multiple pinhole and without wearing pinhole 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 pinhole and without wearing pinhole with one week apart in random order after baseline study | 
| 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). | Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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presbyopia