NCT02111356

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

Same day

First QC Date

April 4, 2014

Last Update Submit

April 9, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Pupil size

    Change from baseline at 1 week

  • Depth of focus

    Change from baseline at 1 week

  • Accomodation

    Change from baseline at 1 week

  • Visual field

    Change from baseline at 1 week

  • Contrast sensitivity

    Change from baseline at 1 week

  • +1 more secondary outcomes

Study Arms (1)

Pinhole glasses

EXPERIMENTAL

All subjects perform ophthalmic examinations before and after the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)

Device: Phinhole glasses

Interventions

Wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)

Pinhole glasses

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Chung-Ang University School of Medicine, Chung-Ang University Hospital

Seoul, Seoul, 156-755, South Korea

Location

Related Publications (1)

  • 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 Officials

  • WonSoo Kim, M.D.

    Ophthalmology, Chung Ang University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
WonSoo Kim

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 11, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations