Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

NCT02722291 | Unknown

• 1 other identifier: ChungAngUHophthalmology
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pinhole

Keywords

presbyopia

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

presbyopia

EXPERIMENTAL

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.)

Interventions

Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.) DEVICE

presbyopia

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 45 years
• spherical equivalents(SE) within ± 3.0 diopters(D)
• normal ocular alignment

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Chung-Ang University Hospital

Seoul, 156-755, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 30460857 DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

KR (1)