Determine Functions of Pinhole Glasses on the Eyes (PH001)

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: Vision, Ocular
• Intervention / Treatment: Device: Phinhole glasses

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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	Check the pupil size using WASCA Analyzer(Carl Zeiss Meditec, Germany)	Change from baseline at 1 week
Depth of focus	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	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	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	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	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

• 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

General Publications

• Kim WS, Park IK, Chun YS. Quantitative analysis of functional changes caused by pinhole glasses. Invest Ophthalmol Vis Sci. 2014 Aug 12;55(10):6679-85. doi: 10.1167/iovs.14-14801.

Study record dates

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