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Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Yonsei University logo

Yonsei University

Status

Completed

Conditions

Presbyopia

Treatments

Device: Pinhole Soft Contact Lens apply for presbyopia

Study type

Interventional

Funder types

Other

Identifiers

NCT02612584
1-2015-0015

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Pinhole soft contact lens
Experimental group
Treatment:
Device: Pinhole Soft Contact Lens apply for presbyopia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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