Functional Vision ChangesNCT02572544
Comparison of Objective and Subjective Changes Induced by Multiple Pinhole Glasses and Single Pinhole Glasses
A study testing Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.) in people with Functional Vision Changes, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Vision Changes
- What is being tested?
- Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 20 and 45 years;
- spherical equivalents (SE) within ± 6.0 diopters (D);
- correctable distant and near visual acuity by glasses up to 20/20;
- normal intraocular pressure with normal optic disc appearance;
- normal ocular alignment.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang University Hospital
Seoul, Seoul, 156-755
WonSoo Kim, MD, +82-2-6299-1666, onewat5@hotmail.com
About this study
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.
- Conditions
- Functional Vision Changes
- Being tested
- Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)
- Keywords
- young healthy adults, single pinhole glasses, multiple pinhole glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)Device
Wearing multiple and single pinhole glasses
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | All participants perform all exams under 3 conditions, that is baseline, single pinhole glasses, and multiple pinhole glasses Receives: Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant visual acuity (logMAR)
Distant visual acuity were measured using Snellen chart (Precision Vision, La Salle, IL, USA) at 4 m.
Measured: Subjects performed this examination while wearing multiple and single pinhole glasses 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).
Measured: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Depth of focus
Monocular DOF was checked with a 4-m Snellen chart under distance correction without cycloplegics.
Measured: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Accommodative amplitude (Diopter)
Near point of accommodation (NPA) was measured using Donder's push-up method.
Measured: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Standard automated perimetry
Visual field (VF) test was performed with a Humphrey Visual Field Analyzer (Carl Zeiss Meditec, Inc., Dublin, CA, USA) using the 30-2 Swedish interactive threshold algorithm.
Measured: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Contrast sensitivity
Monocular contrast sensitivity test was performed using a CSV-1000E Contrast Testing Instrument (VectorVision, Dayton, OH, USA) at 2.5-m distance under standard brightness (85 cd/m2)
Measured: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Stereopsis (seconds of arc)
Stereopsis was checked with the Randot Stereotest (Stereo Optical Co., Chicago, IL, USA).
Measured: Subjects performed this examination while wearing multiple and single pinhole glasses 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. The time taken to read designated 10 pages including 3985 letters was recorded, and then reading speed was calculated as letters per second (LPS).
Measured: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Near visual acuity (logMAR)
Near visual acuity using Logarithmic Visual Acuity Chart 2000 (Precision Vision, La Salle, IL, USA) at 40 cm.
Measured: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Pupil size with the both pinhole glasses (mm)
Pupil size with the both pinhole glasses using the ruler attached to the lateral rim of the glasses.
Measured: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Vision ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WonSoo Kim, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572544
- Sponsor's protocol ID
- ChungAngUHeye
- Status last verified
- Oct 2015
- First submitted
- 7 Oct 2015
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28378561
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Objective and Subjective Changes Induced by Multiple Pinhole Glasses and Single Pinhole Glasses
- ClinicalTrials.gov ID
- NCT02572544
- Acronym / sponsor ID
- ChungAngUHeye
- Conditions
- Functional Vision Changes
- Keywords
- young healthy adults, single pinhole glasses, multiple pinhole glasses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (estimated)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)All participants perform all exams under 3 conditions, that is baseline, single pinhole glasses, and multiple pinhole glasses |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age between 20 and 45 years;
- spherical equivalents (SE) within ± 6.0 diopters (D);
- correctable distant and near visual acuity by glasses up to 20/20;
- normal intraocular pressure with normal optic disc appearance;
- normal ocular alignment.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)Wearing multiple and single pinhole glasses | Device | Participants |
Primary outcome
Distant visual acuity (logMAR)
Time frame: Subjects performed this examination while wearing multiple and single pinhole glasses 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.
Photopic pupil size (baseline, mm)
Time frame: Subjects performed this examination while wearing multiple and single pinhole glasses 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).
Depth of focus
Time frame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Monocular DOF was checked with a 4-m Snellen chart under distance correction without cycloplegics.
Accommodative amplitude (Diopter)
Time frame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Near point of accommodation (NPA) was measured using Donder's push-up method.
Standard automated perimetry
Time frame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Visual field (VF) test was performed with a Humphrey Visual Field Analyzer (Carl Zeiss Meditec, Inc., Dublin, CA, USA) using the 30-2 Swedish interactive threshold algorithm.
Contrast sensitivity
Time frame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Monocular contrast sensitivity test was performed using a CSV-1000E Contrast Testing Instrument (VectorVision, Dayton, OH, USA) at 2.5-m distance under standard brightness (85 cd/m2)
Stereopsis (seconds of arc)
Time frame: Subjects performed this examination while wearing multiple and single pinhole glasses 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)
Time frame: Subjects performed this examination while wearing multiple and single pinhole glasses 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. The time taken to read designated 10 pages including 3985 letters was recorded, and then reading speed was calculated as letters per second (LPS).
Near visual acuity (logMAR)
Time frame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Near visual acuity using Logarithmic Visual Acuity Chart 2000 (Precision Vision, La Salle, IL, USA) at 40 cm.
Pupil size with the both pinhole glasses (mm)
Time frame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.
Pupil size with the both pinhole glasses using the ruler attached to the lateral rim of the glasses.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Derived from this study: PubMed 28378561Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.) in people with Functional Vision Changes, run by Chung-Ang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WonSoo Kim, MD (+82-2-6299-1666, onewat5@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distant visual acuity (logMAR) (time frame: Subjects performed this examination while wearing multiple and single pinhole glasses with one week apart in random order after baseline study.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02572544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.