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Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Primary Purpose

Presbyopia

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Pinhole Soft Contact Lens apply for presbyopia

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pinhole soft contact lens

Arm Description

Outcomes

Primary Outcome Measures

Corrected (with pinhole contact lens) Near Vision Acuity

Defocusing curve

Secondary Outcome Measures

Corneal erosion grade(oxford score)

OSDI(ocular surface disease index)

Visual field test

Contrast sensitivity test

Full Information

NCT ID

NCT02612584

First Posted

November 18, 2015

Last Updated

January 25, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02612584

Brief Title

Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2016 (undefined)

Primary Completion Date

November 15, 2016 (Actual)

Study Completion Date

November 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Presbyopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pinhole soft contact lens

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Pinhole Soft Contact Lens apply for presbyopia

Primary Outcome Measure Information:

Title

Corrected (with pinhole contact lens) Near Vision Acuity

Time Frame