Effect of Multifocal Intraocular Lens on Contrast Sensitivity in Primary Angle-Closure Patients
Primary Purpose
Primary Angle Closure Glaucoma, Primary Angle Glaucoma Closure Suspect, Senile Cataract
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Contrast sensitivity
Sponsored by
About this trial
This is an interventional treatment trial for Primary Angle Closure Glaucoma focused on measuring primary angle closure, primary angle closure glaucoma, cataract surgery, contrast sensitivity, intraocular lens
Eligibility Criteria
Inclusion Criteria:
- Visually significant cataract patients aged >18 years with PAC or PACG who underwent prophylaxis peripheral iridotomy at least 2 months prior to participation.
Exclusion Criteria:
- Patients with preexisting glaucomatous visual field defect, except generalized depression
- Any other concurrent ocular diseases that could affect visual acuity, except cataract
- History of ocular inflammation or ocular surgery, except laser peripheral iridotomy, which is a routine procedure for treating PAC/PACG
Sites / Locations
- Naris Kitnarong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Multifocal intraocular lens group
Monofocal intraocular lens group
Arm Description
Cataract patients with PAC or PACG who underwent phacoemulsification with multifocal intraocular lens implantation.
Cataract patients with PAC or PACG who underwent phacoemulsification with monofocal intraocular lens implantation which are the standard IOL.
Outcomes
Primary Outcome Measures
Contrast sensitivity
Contrast sensitivity at partial frequency 1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree (CPD)
Contrast sensitivity
Contrast sensitivity at partial frequency 1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree (CPD)
Secondary Outcome Measures
Visual acuity
Visual acuity at distance in LogMar
Visual acuity
Visual acuity at distance in LogMar
Anterior chamber depth
Anterior chamber depth
Anterior chamber depth
Anterior chamber depth
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04972435
Brief Title
Effect of Multifocal Intraocular Lens on Contrast Sensitivity in Primary Angle-Closure Patients
Official Title
Effect of Multifocal Intraocular Lens on Contrast Sensitivity in Primary Angle-Closure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2014 (Actual)
Primary Completion Date
December 30, 2015 (Actual)
Study Completion Date
December 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 1.5, 3.0, 6.0, 12.0, and 18.0 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 center's institutional review board (IRB) (approval number Si 384/2014). 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 0.5 and/or 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 (2.2 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 (1.5, 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 Student's t-test for unpaired data, and using Mann-Whitney U test for non-normally distributed data. A p-value of less than 0.05 was defined as denoting statistical significance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Angle Closure Glaucoma, Primary Angle Glaucoma Closure Suspect, Senile Cataract
Keywords
primary angle closure, primary angle closure glaucoma, cataract surgery, contrast sensitivity, intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cataract patients with PAC or PACG who schedule for phacoemulsification with intraocular lens implantation. The patients must decide preoperatively to use multifocal IOL or monofocal IOL (patient preference) after receiving clear information about those 2 IOL models. Postoperatively, the contrast sensitivity (CS)will be measured with the same method. The postoperative CS were compared between groups.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multifocal intraocular lens group
Arm Type
Experimental
Arm Description
Cataract patients with PAC or PACG who underwent phacoemulsification with multifocal intraocular lens implantation.
Arm Title
Monofocal intraocular lens group
Arm Type
Sham Comparator
Arm Description
Cataract patients with PAC or PACG who underwent phacoemulsification with monofocal intraocular lens implantation which are the standard IOL.
Intervention Type
Diagnostic Test
Intervention Name(s)
Contrast sensitivity
Intervention Description
All subjects performed the contrast sensitivity measurement preoperatively and one time at 2 months postoperatively.
Primary Outcome Measure Information:
Title
Contrast sensitivity
Description
Contrast sensitivity at partial frequency 1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree (CPD)
Time Frame
Preoperative (on screening day)
Title
Contrast sensitivity
Description
Contrast sensitivity at partial frequency 1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree (CPD)
Time Frame
At 2nd month postoperatively
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Visual acuity at distance in LogMar
Time Frame
Preoperative (on screening day)
Title
Visual acuity
Description
Visual acuity at distance in LogMar
Time Frame
At 2nd month postoperatively
Title
Anterior chamber depth
Description
Anterior chamber depth
Time Frame
Preoperative (on screening day)
Title
Anterior chamber depth
Description
Anterior chamber depth
Time Frame
At 2nd month postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Visually significant cataract patients aged >18 years with PAC or PACG who underwent prophylaxis peripheral iridotomy at least 2 months prior to participation.
Exclusion Criteria:
Patients with preexisting glaucomatous visual field defect, except generalized depression
Any other concurrent ocular diseases that could affect visual acuity, except cataract
History of ocular inflammation or ocular surgery, except laser peripheral iridotomy, which is a routine procedure for treating PAC/PACG
Facility Information:
Facility Name
Naris Kitnarong
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20040877
Citation
Teichman JC, Ahmed II. Intraocular lens choices for patients with glaucoma. Curr Opin Ophthalmol. 2010 Mar;21(2):135-43. doi: 10.1097/ICU.0b013e3283365154.
Results Reference
result
PubMed Identifier
17722234
Citation
Kim CY, Chung SH, Kim TI, Cho YJ, Yoon G, Seo KY. Comparison of higher-order aberration and contrast sensitivity in monofocal and multifocal intraocular lenses. Yonsei Med J. 2007 Aug 31;48(4):627-33. doi: 10.3349/ymj.2007.48.4.627.
Results Reference
result
PubMed Identifier
17159450
Citation
Kumar BV, Phillips RP, Prasad S. Multifocal intraocular lenses in the setting of glaucoma. Curr Opin Ophthalmol. 2007 Feb;18(1):62-6. doi: 10.1097/ICU.0b013e328011d108.
Results Reference
result
PubMed Identifier
12686237
Citation
Montes-Mico R, Alio JL. Distance and near contrast sensitivity function after multifocal intraocular lens implantation. J Cataract Refract Surg. 2003 Apr;29(4):703-11. doi: 10.1016/s0886-3350(02)01648-6.
Results Reference
result
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Effect of Multifocal Intraocular Lens on Contrast Sensitivity in Primary Angle-Closure Patients
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