Ignite Creation Date:
2024-05-06 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05220007
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2021-12-27
Brief Title:
Effect of Presbyopic Correction Lens on Humphrey Visual Field Testing in Patients With Multifocal Intraocular Lens
Sponsor:
Siriraj Hospital
Organization:
Siriraj Hospital
Study Overview
Official Title:
Effect of Presbyopic Correction Lens on Humphrey Visual Field Testing in Patients With Multifocal Intraocular Lens
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose of this study was to evaluate the effect of presbyopic correction lens on Humphrey visual field HVF testing in patients with 2 models of multifocal intraocular lens MIOL both with and without glaucoma All participants performed HVF testing with presbyopic collection lenses and without presbyopic collection lenses on the same occasion 5-10 minutes between the test The mean deviation MD and pattern standard deviation PSD were compared between with and without presbyopic collection lenses between glaucoma and non-glaucoma and between 2 models of MIOL
Detailed Description:
This was a prospective comparative study in patients who underwent uneventful phacoemulsification with MIOL implantation at the Department of Ophthalmology Faculty of Medicine Siriraj Hospital Mahidol University between June 2009 to July 2012 The study protocol was approved by the Siriraj Institutional Review Board complied with all of the principles set forth in the Declaration of Helsinki 1964 and its subsequent amendments certificate of approval number Si 0032010 The written informed consent was obtained from each participant prior to participation Each patient received a comprehensive eye examination with slit-lamp biomicroscopy distant and near visual acuity and auto-refraction The eligible participants performed HVF 24-2 or 30-2 on the enrollment day with and without presbyopic correction lens The participants were randomized to perform HVF with presbyopic collection lenses followed by without presbyopic collection lenses or without presbyopic collection lenses followed by with presbyopic collection lenses by simple randomization Data collection included demographic data distant logMar and near Jaeger reading chart BCVA and HVF test result including mean deviation MD pattern standard deviation PSD test duration minute fixation loss false positive and false negative
Multifocal intraocular lens characteristics There were two types of aspheric diffractive MIOL included in the study TECNIS ZM900 Abbott Medical Optics Inc Santa Ana CA USA and AcrySof IQ ReSTOR SN6AD1 Alcon Laboratories Inc Irvine CA USA The TECNIS ZM900 is a silicone 3-piece aspheric diffractive lens The power of the add is 400 D with a 5050 distancenear light distribution The AcrySof IQ ReSTOR SN6AD1is an acrylic single-piece aspheric diffractive lens The power of the add is 300 D with a 6535 light distribution
Multifocal intraocular lens characteristics There were two types of aspheric diffractive MIOL included in the study TECNIS ZM900 Abbott Medical Optics Inc Santa Ana CA USA and AcrySof IQ ReSTOR SN6AD1 Alcon Laboratories Inc Irvine CA USA The TECNIS ZM900 is a silicone 3-piece aspheric diffractive lens The power of the add is 400 D with a 5050 distancenear light distribution The AcrySof IQ ReSTOR SN6AD1is an acrylic single-piece aspheric diffractive lens The power of the add is 300 D with a 6535 light distribution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None