Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

Presbyopia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02722291
• Other study ID #: ChungAngUHophthalmology
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2016
• Last updated: March 23, 2016
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2016
• Source: Chung-Ang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pinhole
• Presbyopia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No