Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2016-11-15

Brief Summary

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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.

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WITHDRAWN PHASE4

Detailed Description

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Conditions

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Presbyopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pinhole soft contact lens

Group Type EXPERIMENTAL

Pinhole Soft Contact Lens apply for presbyopia

Intervention Type DEVICE

Interventions

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Pinhole Soft Contact Lens apply for presbyopia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age, 45\~65 years with presbyopia

Exclusion Criteria

* 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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No