Determine Functions of Pinhole Glasses on the Eyes (PH001)

April 9, 2014 updated by: WonSoo Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Quantative Analysis of Functional Changes by the Pinhole Glasses

Pinhole glasses which is using pinhole effect may induce a functional change on the eyes, including Distance and near visual acuity(DVA, NVA), Pupil size, DOF, Accomodative amplitude, CS, Visual field(VF), Stereopsis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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, 156-755
        • Department of Ophthalmology, Chung-Ang University School of Medicine, Chung-Ang University Hospital

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age : between 20 and 50 years old
  • Visual acuity : correctable distant and near visual acuity by glasses up to 20/20
  • Others : Normal intraocular pressure, optic discs with a healthy appearance, and normal ocular alignment.

Exclusion Criteria:

  • History of systemic or topical medication that might affect accommodation
  • Others : Corneal pathologic features, previous ocular surgery, glaucomatous optic discs, glaucoma, cataracts of grade II or greater, vitreous opacity, or retinal abnormalities that might limit the accuracy of test.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pinhole glasses
All subjects perform ophthalmic examinations before and after the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Device: Phinhole glasses
Wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance and near visual acuity(DVA, NVA)
Time Frame: Change from baseline at 1 week

Check distance(4m) and near(40cm) visual acuity using Snellen chart, Visual Acuity chart 2000, respectively.

At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Change from baseline at 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pupil size
Time Frame: Change from baseline at 1 week
Check the pupil size using WASCA Analyzer(Carl Zeiss Meditec, Germany)
Change from baseline at 1 week
Depth of focus
Time Frame: Change from baseline at 1 week

Check with 4m Snellen chart.

At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Change from baseline at 1 week
Accomodation
Time Frame: Change from baseline at 1 week

check by Donder's push-up method. The subject was instructed to view the target letter (20/20 reduced Snellen number), which initially was positioned at approximately 40 cm. The target then was moved progressively closer to the patient's eye at approximately 5 cm per second until the subject noticed the target starting to blur.

At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Change from baseline at 1 week
Visual field
Time Frame: Change from baseline at 1 week

Humphrey Visual Field Analyzer (Carl Zeiss Meditec, Inc., Dublin, CA, USA) using a 30-2 Swedish Interactive Threshold Algorithm

At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Change from baseline at 1 week
Contrast sensitivity
Time Frame: Change from baseline at 1 week

CSV-1000E Contrast Testing Instrument (VectorVision, Dayton, OH, USA) at 2.5m distance under the standard brightness (85 cd/m2)

At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Change from baseline at 1 week
Stereopsis
Time Frame: Change from baseline at 1 week

Randot Stereotest (Stereo Optical Co, Chicago, Illinois, USA)

At 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
Change from baseline at 1 week

Collaborators and Investigators

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

Sponsor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Investigators

  • Principal Investigator: WonSoo Kim, M.D., Ophthalmology, Chung Ang University Hospital

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

April 1, 2014

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • PH-001

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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