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OpenTrials
Completed

NCT Number: NCT02612584

Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pinhole Soft Contact Lens apply for presbyopia

Device

Primary outcomes

  1. Corrected (with pinhole contact lens) Near Vision Acuity

    Time frame: 2 weeks after first apply of pinhole contact lens

  2. Defocusing curve

    Time frame: 2 weeks after first apply of pinhole contact lens

Secondary outcomes

  1. Corneal erosion grade(oxford score)

    Time frame: 2 weeks after first apply of pinhole contact lens

  2. OSDI(ocular surface disease index)

    Time frame: 2 weeks after first apply of pinhole contact lens

  3. Visual field test

    Time frame: 2 weeks after first apply of pinhole contact lens

  4. Contrast sensitivity test

    Time frame: 2 weeks after first apply of pinhole contact lens

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2015
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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