Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia
- Conditions
- Presbyopia
- Interventions
- Device: Pinhole Soft Contact Lens apply for presbyopia
- Registration Number
- NCT02612584
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Age, 45~65 years with presbyopia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pinhole soft contact lens Pinhole Soft Contact Lens apply for presbyopia -
- Primary Outcome Measures
Name Time Method Defocusing curve 2 weeks after first apply of pinhole contact lens Corrected (with pinhole contact lens) Near Vision Acuity 2 weeks after first apply of pinhole contact lens
- Secondary Outcome Measures
Name Time Method OSDI(ocular surface disease index) 2 weeks after first apply of pinhole contact lens Contrast sensitivity test 2 weeks after first apply of pinhole contact lens Visual field test 2 weeks after first apply of pinhole contact lens Corneal erosion grade(oxford score) 2 weeks after first apply of pinhole contact lens
Trial Locations
- Locations (1)
Department of Ophthalmology, Yonsei Univeristy College of Medicine
🇰🇷Seoul, Korea, Republic of