search
Back to results

Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

Primary Purpose

Pinhole

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)
Sponsored by
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pinhole focused on measuring presbyopia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chung-Ang University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

presbyopia

Arm Description

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

Outcomes

Primary Outcome Measures

Distant visual acuity (logMAR)
Distant visual acuity were measured using Snellen chart (Precision Vision, La Salle, IL, USA) at 4 m.
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
Near point of accommodation (NPA)
Near point of accommodation (NPA) was measured using Donder's push-up method.
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.
Stereopsis
Stereopsis was checked with the Randot Stereotest (Stereo Optical Co., Chicago, IL, USA).
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.
Photopic pupil size (baseline, mm)
Pupil size under photopic conditions (85 cd/m2) was measured using a WASCA Analyzer (Carl Zeiss Meditec, Oberkochen, Germany).
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).

Secondary Outcome Measures

Full Information

First Posted
March 21, 2016
Last Updated
March 30, 2016
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02722291
Brief Title
Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pinhole
Keywords
presbyopia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
presbyopia
Arm Type
Experimental
Arm Description
All participants perform all exams under 3 conditions, that is baseline, with out pinhole glasses, and with multiple pinhole glasses
Intervention Type
Device
Intervention Name(s)
Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)
Primary Outcome Measure Information:
Title
Distant visual acuity (logMAR)
Description
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
Title
BUT
Description
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
Title
Near point of accommodation (NPA)
Description
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
Title
The fusional convergence
Description
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
Title
Stereopsis
Description
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
Title
Reading speed (letters per second)
Description
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
Title
Photopic pupil size (baseline, mm)
Description
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
Title
Pupil size with the one eye pinhole glasses (mm)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Hyun Park
Phone
82262991666
Email
sikmuk2@naver.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
30460857
Citation
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.
Results Reference
derived

Learn more about this trial

Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

We'll reach out to this number within 24 hrs