Clinical Trial: Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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 Summary:
Sponsor: Yonsei University

Current 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Yonsei University

Dates:
Date Received: November 18, 2015
Date Started: November 2015
Date Completion: February 2016
Last Updated: November 19, 2015
Last Verified: November 2015