PinholeNCT02722291
Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia
A study testing Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.) in people with Pinhole, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pinhole
- 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
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Mar 2017
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age over 45 years
- spherical equivalents(SE) within ± 3.0 diopters(D)
- 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, 156-755
Hong Hyun Park, 82262991666, sikmuk2@naver.com
About this study
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
- Being tested
- Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)
- Keywords
- presbyopia
- Medical subject headings
- Presbyopia
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
| Study group | Role | What they receive |
|---|---|---|
| presbyopia | Experimental | All participants perform all exams under 3 conditions, that is baseline, with out pinhole glasses, and with 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 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole 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 posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (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 PinholeStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Hyun Park, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722291
- Sponsor's protocol ID
- ChungAngUHophthalmology
- Status last verified
- Mar 2016
- First submitted
- 21 Mar 2016
- Last updated
- 1 Apr 2016
- Results posted
- No
Publications
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.
PubMed 30460857
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia
- ClinicalTrials.gov ID
- NCT02722291
- Acronym / sponsor ID
- ChungAngUHophthalmology
- Conditions
- Pinhole
- Keywords
- presbyopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 30 Mar 2016 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| presbyopia | Experimental | Device: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)All participants perform all exams under 3 conditions, that is baseline, with out pinhole glasses, and with multiple pinhole glasses |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 45 years
- spherical equivalents(SE) within ± 3.0 diopters(D)
- 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.) | Device | presbyopia |
Primary outcome
Distant visual acuity (logMAR)
Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole 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.
BUT
Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study
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
Near point of accommodation (NPA)
Time frame: 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) was measured using Donder's push-up method.
The fusional convergence
Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole with one week apart in random order after baseline study
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.
Stereopsis
Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole 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 pinhole and without wearing pinhole 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.
Photopic pupil size (baseline, mm)
Time frame: Subjects performed this examination while wearing multiple pinhole and without wearing pinhole 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).
Pupil size with the one eye pinhole glasses (mm)
Time frame: 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 was measured using a WASCA Analyzer (Carl Zeiss Meditec, Oberkochen, Germany).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Derived from this study: PubMed 30460857Park 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.
Related trials for Pinhole
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Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
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 Pinhole, 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 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 1 Apr 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 pinhole and without wearing pinhole with one week apart in random order after baseline study). The study lists 8 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 NCT02722291, 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 1 Apr 2016; AzTrials last refreshed its copy on 30 Oct 2026.