Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04972435
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2021-07-12
Brief Title:
Effect of Multifocal Intraocular Lens on Contrast Sensitivity in Primary Angle-Closure Patients
Sponsor:
Siriraj Hospital
Organization:
Siriraj Hospital
Study Overview
Official Title:
Effect of Multifocal Intraocular Lens on Contrast Sensitivity in Primary Angle-Closure Patients
Status:
COMPLETED
Status Verified Date:
2021-07
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:
This prospective study included patients with primary angle-closure PAC or primary angle-closure glaucoma PACG and visually significant cataract Phacoemulsification with multifocal intraocular lens MIOL or monofocal IOL mIOL patient preference was performed Collected data included best-corrected distant visual acuity BCVA intraocular pressure IOP anterior chamber depth ACD and contrast sensitivity CS measured at spatial frequency 15 30 60 120 and 180 cycles per degree CPD preoperatively and at 2-6 months postoperatively Preoperative and postoperative parameters were compared to evaluate the effect of MIOL on CS in eyes with PAC or PACG
Detailed Description:
This prospective non-randomized clinical study was conducted at the Department of Ophthalmology of the Faculty of Medicine Siriraj Hospital Mahidol University Bangkok Thailand during January 2014 to December 2015 The study protocol and informed consent procedures were both approved by our centers institutional review board IRB approval number Si 3842014 Each patient provided written informed consent prior to participation
Primary angle closure was defined as an eye with invisible non-pigmented trabecular meshwork greater than 180 degrees and evidence of peripheral anterior synechiae on gonioscopy without glaucomatous optic disc appearance glaucomatous pattern visual field damage or history of increased IOP Primary angle closure glaucoma was defined as an eye with invisible non-pigmented trabecular meshwork greater than 180 degrees on gonioscopy with glaucomatous optic damage cup-to-disc ratio greater than 05 andor localized neuro-retinal rim defect and history of increased IOP raising Patients with PACG must have been under good disease control which was defined as IOP under 20 mmHg with 1 to 3 topical anti-glaucoma medications without deterioration of visual field except generalized depression from cataract Intra-ocular lens calculation was performed at the baseline visit using IOL Master All patients received information about the advantages and disadvantages of MIOLs Tecnis ZMB00 or Acrysof IQ Restore SN6AD1 and of mIOLs Tecnis ZCB00 or Acrysof IQ SN60WF before choosing the type of IOL that they individually preferred Cataract surgery was performed by a single surgeon Topical anesthesia was applied before standard phacoemulsification 22 mm temporal clear cornea incision and continuous curvilinear capsulorhexis and IOL implantation into the capsular bag Eyes with any intraoperative or postoperative complication were excluded
Data specific to uncorrected and best-corrected distant visual acuities UCVA and BCVA in logMar auto-refraction slit-lamp ophthalmoscopic examination intraocular pressure IOP measurement with Goldmann applanation tonometry contrast sensitivity CS anterior chamber depth ACD central corneal thickness CCT and axial length AL were collected on the preoperative screening day and at the 2 to 6-month postoperative follow-up CS was measured under normal room light photopic conditions to evaluate patient quality of vision during the performance of their daily activities using a Functional Vision Analyzer This test produces sine-wave gratings of different spatial frequencies The absolute values of distance CS were obtained at five spatial frequencies 15 3 6 12 and 18 cycles per degree CPD Visante AS-OCT was used to determine CCT and ACD ACD was defined as the distance between the corneal endothelium and the anterior surface of the crystalline lens preoperative or iris plane postoperative Axial length was obtained using IOL Master
Comparisons of continuous data with normal distribution were made using Students t-test for unpaired data and using Mann-Whitney U test for non-normally distributed data A p-value of less than 005 was defined as denoting statistical significance
Primary angle closure was defined as an eye with invisible non-pigmented trabecular meshwork greater than 180 degrees and evidence of peripheral anterior synechiae on gonioscopy without glaucomatous optic disc appearance glaucomatous pattern visual field damage or history of increased IOP Primary angle closure glaucoma was defined as an eye with invisible non-pigmented trabecular meshwork greater than 180 degrees on gonioscopy with glaucomatous optic damage cup-to-disc ratio greater than 05 andor localized neuro-retinal rim defect and history of increased IOP raising Patients with PACG must have been under good disease control which was defined as IOP under 20 mmHg with 1 to 3 topical anti-glaucoma medications without deterioration of visual field except generalized depression from cataract Intra-ocular lens calculation was performed at the baseline visit using IOL Master All patients received information about the advantages and disadvantages of MIOLs Tecnis ZMB00 or Acrysof IQ Restore SN6AD1 and of mIOLs Tecnis ZCB00 or Acrysof IQ SN60WF before choosing the type of IOL that they individually preferred Cataract surgery was performed by a single surgeon Topical anesthesia was applied before standard phacoemulsification 22 mm temporal clear cornea incision and continuous curvilinear capsulorhexis and IOL implantation into the capsular bag Eyes with any intraoperative or postoperative complication were excluded
Data specific to uncorrected and best-corrected distant visual acuities UCVA and BCVA in logMar auto-refraction slit-lamp ophthalmoscopic examination intraocular pressure IOP measurement with Goldmann applanation tonometry contrast sensitivity CS anterior chamber depth ACD central corneal thickness CCT and axial length AL were collected on the preoperative screening day and at the 2 to 6-month postoperative follow-up CS was measured under normal room light photopic conditions to evaluate patient quality of vision during the performance of their daily activities using a Functional Vision Analyzer This test produces sine-wave gratings of different spatial frequencies The absolute values of distance CS were obtained at five spatial frequencies 15 3 6 12 and 18 cycles per degree CPD Visante AS-OCT was used to determine CCT and ACD ACD was defined as the distance between the corneal endothelium and the anterior surface of the crystalline lens preoperative or iris plane postoperative Axial length was obtained using IOL Master
Comparisons of continuous data with normal distribution were made using Students t-test for unpaired data and using Mann-Whitney U test for non-normally distributed data A p-value of less than 005 was defined as denoting statistical significance
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