PresbyopiaNCT02612584

Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

A study testing Pinhole Soft Contact Lens apply for presbyopia in people with Presbyopia, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 45 to 65 years
Conditions the study is for: Presbyopia
What is being tested?: Pinhole Soft Contact Lens apply for presbyopia
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: 1 Jan 2016to 15 Nov 2016
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age, 45~65 years with presbyopia

Who cannot join

Patients with anterior segment pathology,
Patients with previous intraocular or corneal surgery,
Patients with severe cataracts,
Patients with corneal abnormalities( including endothelial dystrophy, recurrent corneal erosion, etc.),
Patients with history of chronic dry eye, macular degeneration,
Patients with retinal detachment, or any other fundus pathology

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Department of Ophthalmology, Yonsei Univeristy College of Medicine
Seoul, 03722

Other trials in South Korea

About this study

For correct of presbyopia, in this study, the investigators have recruited subjects who aged 45~65 years with presbyopia and do not have any other ocular disease(ex, ocular surface disease, corneal dystrophy, retinal disorders, etc.). All participants will underwent ophthalmic examination including manifest refraction, uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), corrected near visual acuity(CNVA), Goldmann visual field test, depth of focus Contrast sensitivity test, slit-lamp examination, topography with scheimp flug device(OCULUS pentacam ®) OSDI(ocular surface disease index) and Questionnaire about visual function and ocular symptoms. Apply pinhole soft contact lens (eyelike NoanPinhole ® , seoul, south Korea, Koryo Eyetech) on non-dominant eye of participants and/or soft contact lens for distance vision on dominant eye of participants. The investigators recommend use of pinhole contact lens at least 3 hours in a day for 1 week. And, participant will underwent the all ophthalmic examination same above 2 weeks after first apply of pinhole contact lens. The investigators will compare ophthalmic parameters mentioned above before and after wearing pinhole contact lens and evaluate the efficacy and safety of pinhole soft contact lens for correcting presbyopia.

Conditions: Presbyopia
Being tested: Pinhole Soft Contact Lens apply for presbyopia
Medical subject headings: Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pinhole Soft Contact Lens apply for presbyopiaDevice

Study groups in NCT02612584
Study group	Role	What they receive
Pinhole soft contact lens	Experimental	Not described Receives: Device: Pinhole Soft Contact Lens apply for presbyopia

What is being measured

The primary outcome is the main question the study is designed to answer.

Corrected (with pinhole contact lens) Near Vision Acuity
Measured: 2 weeks after first apply of pinhole contact lens
Defocusing curve
Measured: 2 weeks after first apply of pinhole contact lens

Secondary outcomes (4)

Corneal erosion grade(oxford score)
Measured: 2 weeks after first apply of pinhole contact lens
OSDI(ocular surface disease index)
Measured: 2 weeks after first apply of pinhole contact lens
Visual field test
Measured: 2 weeks after first apply of pinhole contact lens
Contrast sensitivity test
Measured: 2 weeks after first apply of pinhole contact lens

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201615 Nov 2016

First posted24 Nov 2015 (estimated)
Study start1 Jan 2016
Primary completion15 Nov 2016
Study completion15 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for PresbyopiaStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe sponsor's other registered studies.
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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02612584
Sponsor's protocol ID: 1-2015-0015
Status last verified: Jan 2019
First submitted: 18 Nov 2015
Last updated: 29 Jan 2019
Results posted: No
Data monitoring committee: No

Publications

Schwiegerling J. Predicting clinical visual acuity of presbyopia treatments. J Refract Surg. 2010 Jan;26(1):66-70. doi: 10.3928/1081597X-20101215-11.
PubMed 20199016
Garcia-Lazaro S, Ferrer-Blasco T, Radhakrishnan H, Albarran-Diego C, Montes-Mico R. Visual comparison of an artificial pupil contact lens to monovision. Optom Vis Sci. 2012 Jul;89(7):E1022-9. doi: 10.1097/OPX.0b013e31825da324.
PubMed 22729169
Charman WN. Developments in the correction of presbyopia I: spectacle and contact lenses. Ophthalmic Physiol Opt. 2014 Jan;34(1):8-29. doi: 10.1111/opo.12091. Epub 2013 Nov 10.
PubMed 24205890
Callina T, Reynolds TP. Traditional methods for the treatment of presbyopia: spectacles, contact lenses, bifocal contact lenses. Ophthalmol Clin North Am. 2006 Mar;19(1):25-33, v. doi: 10.1016/j.ohc.2005.09.006.
PubMed 16500526

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia

All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia
ClinicalTrials.gov ID: NCT02612584
Acronym / sponsor ID: 1-2015-0015
Conditions: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: 1 Jan 2016
Primary completion: 15 Nov 2016 (actual)
Study completion: 15 Nov 2016 (actual)
First posted: 24 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pinhole soft contact lens	Experimental	Device: Pinhole Soft Contact Lens apply for presbyopia

Who may qualify

Ages: 45 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Age, 45~65 years with presbyopia

Key exclusion criteria (6 listed)

Patients with anterior segment pathology,
Patients with previous intraocular or corneal surgery,
Patients with severe cataracts,
Patients with corneal abnormalities( including endothelial dystrophy, recurrent corneal erosion, etc.),
Patients with history of chronic dry eye, macular degeneration,

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
Pinhole Soft Contact Lens apply for presbyopia	Device	Pinhole soft contact lens

Primary outcome

Corrected (with pinhole contact lens) Near Vision Acuity
Time frame: 2 weeks after first apply of pinhole contact lens
Defocusing curve
Time frame: 2 weeks after first apply of pinhole contact lens

4 secondary outcomes

Corneal erosion grade(oxford score)
Time frame: 2 weeks after first apply of pinhole contact lens
OSDI(ocular surface disease index)
Time frame: 2 weeks after first apply of pinhole contact lens
Visual field test
Time frame: 2 weeks after first apply of pinhole contact lens
Contrast sensitivity test
Time frame: 2 weeks after first apply of pinhole contact lens

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
Background: PubMed 20199016Schwiegerling J. Predicting clinical visual acuity of presbyopia treatments. J Refract Surg. 2010 Jan;26(1):66-70. doi: 10.3928/1081597X-20101215-11.
Background: PubMed 22729169Garcia-Lazaro S, Ferrer-Blasco T, Radhakrishnan H, Albarran-Diego C, Montes-Mico R. Visual comparison of an artificial pupil contact lens to monovision. Optom Vis Sci. 2012 Jul;89(7):E1022-9. doi: 10.1097/OPX.0b013e31825da324.
Background: PubMed 24205890Charman WN. Developments in the correction of presbyopia I: spectacle and contact lenses. Ophthalmic Physiol Opt. 2014 Jan;34(1):8-29. doi: 10.1111/opo.12091. Epub 2013 Nov 10.
Background: PubMed 16500526Callina T, Reynolds TP. Traditional methods for the treatment of presbyopia: spectacles, contact lenses, bifocal contact lenses. Ophthalmol Clin North Am. 2006 Mar;19(1):25-33, v. doi: 10.1016/j.ohc.2005.09.006.

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pinhole Soft Contact Lens apply for presbyopia in people with Presbyopia, run by Yonsei University 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jan 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Corrected (with pinhole contact lens) Near Vision Acuity (time frame: 2 weeks after first apply of pinhole contact lens). The study lists 2 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 NCT02612584, which also lists 4 linked publications.

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 29 Jan 2019.