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Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Not Applicable
Completed
Conditions
Presbyopia
Interventions
Device: Pinhole Soft Contact Lens apply for presbyopia
Registration Number
NCT02612584
Lead Sponsor
Yonsei University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • Age, 45~65 years with presbyopia
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Pinhole soft contact lensPinhole Soft Contact Lens apply for presbyopia-
Primary Outcome Measures
NameTimeMethod
Defocusing curve2 weeks after first apply of pinhole contact lens
Corrected (with pinhole contact lens) Near Vision Acuity2 weeks after first apply of pinhole contact lens
Secondary Outcome Measures
NameTimeMethod
OSDI(ocular surface disease index)2 weeks after first apply of pinhole contact lens
Contrast sensitivity test2 weeks after first apply of pinhole contact lens
Visual field test2 weeks after first apply of pinhole contact lens
Corneal erosion grade(oxford score)2 weeks after first apply of pinhole contact lens

Trial Locations

Locations (1)

Department of Ophthalmology, Yonsei Univeristy College of Medicine

🇰🇷

Seoul, Korea, Republic of

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