Vision, OcularPH001NCT02111356
Determine Functions of Pinhole Glasses on the Eyes
A study testing Phinhole glasses in people with Vision, Ocular, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial summary
Pinhole glasses which is using pinhole effect may induce a functional change on the eyes, including Distance and near visual acuity(DVA, NVA), Pupil size, DOF, Accomodative amplitude, CS, Visual field(VF), Stereopsis. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision, Ocular
- What is being tested?
- Phinhole glasses
- 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
- Apr 2014to Apr 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age : between 20 and 50 years old
- Visual acuity : correctable distant and near visual acuity by glasses up to 20/20
- Others : Normal intraocular pressure, optic discs with a healthy appearance, and normal ocular alignment.
Who cannot join
- History of systemic or topical medication that might affect accommodation
- Others : Corneal pathologic features, previous ocular surgery, glaucomatous optic discs, glaucoma, cataracts of grade II or greater, vitreous opacity, or retinal abnormalities that might limit the accuracy of test.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Chung-Ang University School of Medicine, Chung-Ang University Hospital
Seoul, Seoul, 156-755
About this study
Official title: Quantative Analysis of Functional Changes by the Pinhole Glasses
Pinhole glasses which is using pinhole effect may induce a functional change on the eyes, including Distance and near visual acuity(DVA, NVA), Pupil size, DOF, Accomodative amplitude, CS, Visual field(VF), Stereopsis.
- Conditions
- Vision, Ocular
- Being tested
- Phinhole glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phinhole glassesDevice
Wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
| Study group | Role | What they receive |
|---|---|---|
| Pinhole glasses | Experimental | All subjects perform ophthalmic examinations before and after the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.) Receives: Device: Phinhole glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance and near visual acuity(DVA, NVA)
Check distance(4m) and near(40cm) visual acuity using Snellen chart, Visual Acuity chart 2000, respectively.
At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Measured: Change from baseline at 1 week
Secondary outcomes (6)
Pupil size
Check the pupil size using WASCA Analyzer(Carl Zeiss Meditec, Germany)
Measured: Change from baseline at 1 week
Depth of focus
Check with 4m Snellen chart.
At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Measured: Change from baseline at 1 week
Accomodation
check by Donder's push-up method. The subject was instructed to view the target letter (20/20 reduced Snellen number), which initially was positioned at approximately 40 cm. The target then was moved progressively closer to the patient's eye at approximately 5 cm per second until the subject noticed the target starting to blur.
At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Measured: Change from baseline at 1 week
Visual field
Humphrey Visual Field Analyzer (Carl Zeiss Meditec, Inc., Dublin, CA, USA) using a 30-2 Swedish Interactive Threshold Algorithm
At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Measured: Change from baseline at 1 week
Contrast sensitivity
CSV-1000E Contrast Testing Instrument (VectorVision, Dayton, OH, USA) at 2.5m distance under the standard brightness (85 cd/m2)
At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Measured: Change from baseline at 1 week
Stereopsis
Randot Stereotest (Stereo Optical Co, Chicago, Illinois, USA)
At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Measured: Change from baseline at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (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 Vision, OcularStudies 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
- Investigators
- WonSoo Kim, M.D., Principal investigator, Ophthalmology, Chung Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111356
- Sponsor's protocol ID
- PH-001
- Acronym
- PH001
- Status last verified
- Apr 2014
- First submitted
- 4 Apr 2014
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim WS, Park IK, Chun YS. Quantitative analysis of functional changes caused by pinhole glasses. Invest Ophthalmol Vis Sci. 2014 Aug 12;55(10):6679-85. doi: 10.1167/iovs.14-14801.
PubMed 25118263
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantative Analysis of Functional Changes by the Pinhole Glasses
- ClinicalTrials.gov ID
- NCT02111356
- Acronym / sponsor ID
- PH001 / PH-001
- Conditions
- Vision, Ocular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 11 Apr 2014 (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.
Pinhole glasses which is using pinhole effect may induce a functional change on the eyes, including Distance and near visual acuity(DVA, NVA), Pupil size, DOF, Accomodative amplitude, CS, Visual field(VF), Stereopsis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pinhole glasses | Experimental | Device: Phinhole glassesAll subjects perform ophthalmic examinations before and after the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age : between 20 and 50 years old
- Visual acuity : correctable distant and near visual acuity by glasses up to 20/20
- Others : Normal intraocular pressure, optic discs with a healthy appearance, and normal ocular alignment.
Key exclusion criteria (2 listed)
- History of systemic or topical medication that might affect accommodation
- Others : Corneal pathologic features, previous ocular surgery, glaucomatous optic discs, glaucoma, cataracts of grade II or greater, vitreous opacity, or retinal abnormalities that might limit the accuracy of test.
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 |
|---|---|---|
| Phinhole glassesWearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.) | Device | Pinhole glasses |
Primary outcome
Distance and near visual acuity(DVA, NVA)
Time frame: Change from baseline at 1 week
Check distance(4m) and near(40cm) visual acuity using Snellen chart, Visual Acuity chart 2000, respectively. At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
6 secondary outcomes
Pupil size
Time frame: Change from baseline at 1 week
Depth of focus
Time frame: Change from baseline at 1 week
Accomodation
Time frame: Change from baseline at 1 week
Visual field
Time frame: Change from baseline at 1 week
Contrast sensitivity
Time frame: Change from baseline at 1 week
Stereopsis
Time frame: Change from baseline at 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Derived from this study: PubMed 25118263Kim WS, Park IK, Chun YS. Quantitative analysis of functional changes caused by pinhole glasses. Invest Ophthalmol Vis Sci. 2014 Aug 12;55(10):6679-85. doi: 10.1167/iovs.14-14801.
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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.
WonSoo Kim, M.D. principal investigator
Ophthalmology, Chung Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phinhole glasses in people with Vision, Ocular, 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 3 inclusion and 2 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 11 Apr 2014. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance and near visual acuity(DVA, NVA) (time frame: Change from baseline at 1 week). 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 NCT02111356, 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 11 Apr 2014.