Clinical trial NCT02612584: Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Corrected (with pinhole contact lens) Near Vision Acuity
timeFrame: 2 weeks after first apply of pinhole contact lens
measure: Defocusing curve
timeFrame: 2 weeks after first apply of pinhole contact lens
Secondary outcomes:
measure: Corneal erosion grade(oxford score)
timeFrame: 2 weeks after first apply of pinhole contact lens
measure: OSDI(ocular surface disease index)
timeFrame: 2 weeks after first apply of pinhole contact lens
measure: Visual field test
timeFrame: 2 weeks after first apply of pinhole contact lens
measure: Contrast sensitivity test
timeFrame: 2 weeks after first apply of pinhole contact lens
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Yonsei Univeristy College of Medicine
Study officials:
References:
citation: Schwiegerling J. Predicting clinical visual acuity of presbyopia treatments. J Refract Surg. 2010 Jan;26(1):66-70. doi: 10.3928/1081597X-20101215-11.
citation: 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.
citation: 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.
citation: 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.