Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Presbyopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612584
• Other study ID #: 1-2015-0015
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: November 15, 2016

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 15, 2016
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Pinhole Soft Contact Lens apply for presbyopia

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Yonsei Univeristy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. Review. — View 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. Review. — View Citation

García-Lázaro S, Ferrer-Blasco T, Radhakrishnan H, Albarrán-Diego C, Montés-Micó 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected (with pinhole contact lens) Near Vision Acuity		2 weeks after first apply of pinhole contact lens
Primary	Defocusing curve		2 weeks after first apply of pinhole contact lens
Secondary	Corneal erosion grade(oxford score)		2 weeks after first apply of pinhole contact lens
Secondary	OSDI(ocular surface disease index)		2 weeks after first apply of pinhole contact lens
Secondary	Visual field test		2 weeks after first apply of pinhole contact lens
Secondary	Contrast sensitivity test		2 weeks after first apply of pinhole contact lens