Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

January 25, 2019 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Ophthalmology, Yonsei Univeristy College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pinhole soft contact lens
Device: Pinhole Soft Contact Lens apply for presbyopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corrected (with pinhole contact lens) Near Vision Acuity
Time Frame: 2 weeks after first apply of pinhole contact lens
2 weeks after first apply of pinhole contact lens
Defocusing curve
Time Frame: 2 weeks after first apply of pinhole contact lens
2 weeks after first apply of pinhole contact lens

Secondary Outcome Measures

Outcome Measure
Time Frame
Corneal erosion grade(oxford score)
Time Frame: 2 weeks after first apply of pinhole contact lens
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
2 weeks after first apply of pinhole contact lens
Visual field test
Time Frame: 2 weeks after first apply of pinhole contact lens
2 weeks after first apply of pinhole contact lens
Contrast sensitivity test
Time Frame: 2 weeks after first apply of pinhole contact lens
2 weeks after first apply of pinhole contact lens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

November 15, 2016

Study Completion (Actual)

November 15, 2016

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2015-0015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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