Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Study Overview
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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.

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Pinhole Soft Contact Lens apply for presbyopia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pinhole soft contact lens<br> | Device: Pinhole Soft Contact Lens apply for presbyopia<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |