NCT02612584

Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Completed NA Last updated 29 January 2019

What this trial tests

NA trial testing Pinhole Soft Contact Lens apply for presbyopia in Presbyopia in 30 participants. Completed in 15 November 2016.

Timeline

1 January 2016

Primary endpoint
15 November 2016

15 November 2016

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 January 2016
Primary completion	15 November 2016
Estimated completion	15 November 2016
Sites	1 location across South Korea

Drugs / interventions tested

• Pinhole Soft Contact Lens apply for presbyopia

Conditions studied

• Presbyopia — all drugs for Presbyopia →

Sponsor

Yonsei University

Who can join

Adults 45 to 65, any sex, with Presbyopia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.