Determine Functions of Pinhole Glasses on the Eyes

Vision, Ocular Clinical Trial

— PH001  

Official title:

Quantative Analysis of Functional Changes by the Pinhole Glasses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02111356
• Other study ID #: PH-001
• Status: Active, not recruiting
• Phase: N/A
• First received: April 4, 2014
• Last updated: April 9, 2014
• Start date: April 2014
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Chung-Ang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vision, Ocular

Intervention

Device:
• Phinhole glasses
Wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Chung-Ang University School of Medicine, Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pupil size	Check the pupil size using WASCA Analyzer(Carl Zeiss Meditec, Germany)	Change from baseline at 1 week	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes