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Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02612584
Enrollment
30
Registered
2015-11-24
Start date
2016-01-01
Completion date
2016-11-15
Last updated
2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Brief summary

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.

Interventions

DEVICEPinhole Soft Contact Lens apply for presbyopia

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age, 45\ 65 years with presbyopia

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Corrected (with pinhole contact lens) Near Vision Acuity2 weeks after first apply of pinhole contact lens
Defocusing curve2 weeks after first apply of pinhole contact lens

Secondary

MeasureTime frame
Corneal erosion grade(oxford score)2 weeks after first apply of pinhole contact lens
OSDI(ocular surface disease index)2 weeks after first apply of pinhole contact lens
Visual field test2 weeks after first apply of pinhole contact lens
Contrast sensitivity test2 weeks after first apply of pinhole contact lens

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026