Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

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.

Study Overview

• Status: Unknown
• Conditions: Pinhole
• Intervention / Treatment: Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-755
    • Recruiting
    • Chung-Ang University Hospital
    • Contact: Hong Hyun Park; Phone Number: 82262991666; Email: sikmuk2@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Estimate): April 1, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: presbyopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: ChungAngUHophthalmology