Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

Not Applicable

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

• Registration Number: NCT02722291
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-04-01
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
presbyopia	Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)	All participants perform all exams under 3 conditions, that is baseline, with out pinhole glasses, and with multiple pinhole glasses

Primary Outcome Measures

Name	Time	Method
Pupil size with the one eye pinhole glasses (mm)	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).
Stereopsis	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).
Reading speed (letters per second)	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.
Distant visual acuity (logMAR)	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.
The fusional convergence	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.
BUT	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
Near point of accommodation (NPA)	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.
Photopic pupil size (baseline, mm)	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).

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of