Clinical trial NCT02572544: Comparison of Objective and Subjective Changes Induced by Multiple Pinhole Glasses and Single Pinhole Glasses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Vision Changes
Keywords: young healthy adults
single pinhole glasses
multiple pinhole glasses
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose of this study is to compare the ocular functional changes including pupil size, visual acuity, depth of focus, accommodative amplitude, visual field, contrast sensitivity, and stereopsis induced by multiple and single pinhole glasses, in addition, to check reading speed and survey for ocular discomfort after using both pinhole glasses.


Eligibility criteria: Inclusion Criteria:

1. age between 20 and 45 years;
2. spherical equivalents (SE) within ± 6.0 diopters (D);
3. correctable distant and near visual acuity by glasses up to 20/20;
4. normal intraocular pressure with normal optic disc appearance;
5. 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 and single pinhole glasses with one week apart in random order after baseline study.
measure: Photopic pupil size (baseline, mm)
timeFrame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
measure: Depth of focus
timeFrame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
measure: Accommodative amplitude (Diopter)
timeFrame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
measure: Standard automated perimetry
timeFrame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
measure: Contrast sensitivity
timeFrame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
measure: Stereopsis (seconds of arc)
timeFrame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
measure: Reading speed (letters per second)
timeFrame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
measure: Near visual acuity (logMAR)
timeFrame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
measure: Pupil size with the both pinhole glasses (mm)
timeFrame: Subjects performed this examination while wearing multiple and single pinhole glasses 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: Kim WS, Park IK, Park YK, Chun YS. Comparison of Objective and Subjective Changes Induced by Multiple-Pinhole Glasses and Single-Pinhole Glasses. J Korean Med Sci. 2017 May;32(5):850-857. doi: 10.3346/jkms.2017.32.5.850.