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Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

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ClinicalTrials.gov Identifier: NCT02722291
Recruitment Status : Unknown
Verified March 2016 by Hong Hyun Park, Chung-Ang University Hosptial, Chung-Ang University College of Medicine.
Recruitment status was:  Recruiting
First Posted : March 30, 2016
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hong Hyun Park, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : March 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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.)



Primary Outcome Measures :
  1. Distant visual acuity (logMAR) [ Time Frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole 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. BUT [ Time Frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study ]
    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

  3. Near point of accommodation (NPA) [ Time Frame: 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) was measured using Donder's push-up method.

  4. The fusional convergence [ Time Frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study ]
    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.

  5. Stereopsis [ Time Frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study ]
    Stereopsis was checked with the Randot Stereotest (Stereo Optical Co., Chicago, IL, USA).

  6. Reading speed (letters per second) [ Time Frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole 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.

  7. Photopic pupil size (baseline, mm) [ Time Frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole 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).

  8. Pupil size with the one eye pinhole glasses (mm) [ Time Frame: 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 was measured using a WASCA Analyzer (Carl Zeiss Meditec, Oberkochen, Germany).



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age over 45 years
  2. spherical equivalents(SE) within ± 3.0 diopters(D)
  3. 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): NCT02722291


Locations
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Korea, Republic of
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 156-755
Contact: Hong Hyun Park    82262991666    sikmuk2@naver.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):
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Responsible Party: Hong Hyun Park, Principal investigator, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
ClinicalTrials.gov Identifier: NCT02722291     History of Changes
Other Study ID Numbers: ChungAngUHophthalmology
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016

Keywords provided by Hong Hyun Park, Chung-Ang University Hosptial, Chung-Ang University College of Medicine:
presbyopia

Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors