NCT02612584

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 18, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2016

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

November 18, 2015

Last Update Submit

January 25, 2019

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

  • Corrected (with pinhole contact lens) Near Vision Acuity

    2 weeks after first apply of pinhole contact lens

  • Defocusing curve

    2 weeks after first apply of pinhole contact lens

Secondary Outcomes (4)

  • Corneal erosion grade(oxford score)

    2 weeks after first apply of pinhole contact lens

  • OSDI(ocular surface disease index)

    2 weeks after first apply of pinhole contact lens

  • Visual field test

    2 weeks after first apply of pinhole contact lens

  • Contrast sensitivity test

    2 weeks after first apply of pinhole contact lens

Study Arms (1)

Pinhole soft contact lens

EXPERIMENTAL
Device: Pinhole Soft Contact Lens apply for presbyopia

Interventions

Pinhole Soft Contact Lens apply for presbyopiaDEVICE
Pinhole soft contact lens

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age, 45\~65 years with presbyopia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (4)

  • Schwiegerling J. Predicting clinical visual acuity of presbyopia treatments. J Refract Surg. 2010 Jan;26(1):66-70. doi: 10.3928/1081597X-20101215-11.

    PMID: 20199016BACKGROUND

  • Garcia-Lazaro S, Ferrer-Blasco T, Radhakrishnan H, Albarran-Diego C, Montes-Mico R. Visual comparison of an artificial pupil contact lens to monovision. Optom Vis Sci. 2012 Jul;89(7):E1022-9. doi: 10.1097/OPX.0b013e31825da324.

    PMID: 22729169BACKGROUND

  • Charman WN. Developments in the correction of presbyopia I: spectacle and contact lenses. Ophthalmic Physiol Opt. 2014 Jan;34(1):8-29. doi: 10.1111/opo.12091. Epub 2013 Nov 10.

    PMID: 24205890BACKGROUND

  • Callina T, Reynolds TP. Traditional methods for the treatment of presbyopia: spectacles, contact lenses, bifocal contact lenses. Ophthalmol Clin North Am. 2006 Mar;19(1):25-33, v. doi: 10.1016/j.ohc.2005.09.006.

    PMID: 16500526BACKGROUND

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 24, 2015

Study Start

January 1, 2016

Primary Completion

November 15, 2016

Study Completion

November 15, 2016

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

KR(1)