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Clinical outcomes after new monofocal intraocular lens with extended depth of focus(Eyhance) implantations

Status Approved

First Submitted Date

2020/12/14
Registered Date

2020/12/29
Last Updated Date

2020/12/21

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005713
Unique Protocol ID	2020-0302
Public/Brief Title	Clinical outcomes after new monofocal intraocular lens with extended depth of focus(Eyhance) implantations
Scientific Title	Clinical outcomes after new monofocal intraocular lens with extended depth of focus(Eyhance) implantations
Acronym	Eyhance study
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2020-0302
Approval Date	2020-03-12
Institutional Review Board Name	Asan medical center institutional review board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Hungwon Tchah
Title	Dr
Telephone	+82-2-3010-3680
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Contact Person for Public Queries
Name	Hungwon Tchah
Title	Dr
Telephone	+82-2-3010-3680
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Contact Person for Updating Information
Name	Hungwon Tchah
Title	Dr
Telephone	+82-2-3010-3680
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-05-26 Actual
Target Number of Participant	40
Primary Completion Date	2021-12-31 , Anticipated
Study Completion Date	2021-12-31 , Anticipated
Name of Study	Asan Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2020-05-26 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Asan Medical Center
Organization Type	Medical Institute
Project ID	2020-0302

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Cataract surgery has been developed for a long time, and recently inserting multifocal intraocular lens is regarded as a correction method for senile cataract with presbyopia. However, many patients complain of glare and halo after multifocal intraocular lens implantation, therefore exteded-depth-of-focus intraocular lens which can offer good intermediate visual acuity with no adverse effects of multifocal intraocular lens are gaining more and more popularity. We will evaluate the postoperative visual function and visual quality of the subjects with new extended-depth-of-focus intraocular lens(Eyhance) being inserted.

Study Summary Information

Lay Summary

Cataract surgery has been developed for a long time, and recently inserting multifocal intraocular lens is regarded as a correction method for senile cataract with presbyopia. However, many patients complain of glare and halo after multifocal intraocular lens implantation, therefore exteded-depth-of-focus intraocular lens which can offer good intermediate visual acuity with no adverse effects of multifocal intraocular lens are gaining more and more popularity. We will evaluate the postoperative visual function and visual quality of the subjects with new extended-depth-of-focus intraocular lens(Eyhance) being inserted.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Non-RCT
Intervention Type	Medical Device
Intervention Description	As single group intervention model, extended-depth-of-focus intraocular lenses were implanted binocularly during cataract surgery.
Number of Arms	1
Arm 1	Arm Label extended-depth-of-focus intraocular lens group
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description As single group intervention model, extended-depth-of-focus intraocular lenses were implanted binocularly during cataract surgery.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (H00-H59)Diseases of the eye and adnexa (H25.92)Senile cataract, unspecified, bilateral Bilateral cataract patients
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 21Year~80Year
	Description adults with significant bilateral immature cataract, less than 1.0 D corneal astigmatism, and potential acuity meter visual acuity greater than 0.1 logMAR
Exclusion Criteria	subjects who had undergone previous ocular surgery or trauma, had corneal opacity, retinopathy, glaucoma, uveitis, or amblyopia, or experienced complications such as posterior capsule rupture during the surgery.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Uncorrected monocular distance visual acuity
Timepoint	preoperatively and at a month and 3 months postoperatively
Primary Outcome(s) 2
Outcome	Uncorrected binocular distance visual acuity
Timepoint	preoperatively and at a month and 3 months postoperatively
Primary Outcome(s) 3
Outcome	Uncorrected intermediate visual acuity
Timepoint	preoperatively and at a month and 3 months postoperatively
Primary Outcome(s) 4
Outcome	Uncorrected near visual acuity
Timepoint	preoperatively and at a month and 3 months postoperatively
Primary Outcome(s) 5
Outcome	corrected monocular distance visual acuity
Timepoint	preoperatively and at a month and 3 months postoperatively
Primary Outcome(s) 6
Outcome	corrected binocular distance visual acuity
Timepoint	preoperatively and at a month and 3 months postoperatively
Primary Outcome(s) 7
Outcome	autorefraction
Timepoint	preoperatively and at a month and 3 months postoperatively
Primary Outcome(s) 8
Outcome	monocular and binocular defocus curves
Timepoint	preoperatively and at a month and 3 months postoperatively
Primary Outcome(s) 9
Outcome	contrast sensitivity
Timepoint	preoperatively and at a month and 3 months postoperatively
Primary Outcome(s) 10
Outcome	satisfaction questionnaire
Timepoint	preoperatively and at a month and 3 months postoperatively
Secondary Outcome(s) 1
Outcome	Intraocular pressure
Timepoint	preoperatively and at a month and 3 months postoperatively

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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