Clinical trial NCT02722291: Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pinhole
Keywords: presbyopia
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distant visual acuity (logMAR)
timeFrame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study
measure: BUT
timeFrame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study
measure: Near point of accommodation (NPA)
timeFrame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study
measure: The fusional convergence
timeFrame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study
measure: Stereopsis
timeFrame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study
measure: Reading speed (letters per second)
timeFrame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study
measure: Photopic pupil size (baseline, mm)
timeFrame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study
measure: Pupil size with the one eye pinhole glasses (mm)
timeFrame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
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.