Effect of Presbyopic Correction Lens on Humphrey Visual Field Testing in Patients With Multifocal Intraocular Lens

Study Overview
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Brief Summary
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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
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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 003/2010). 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 +4.00 D with a 50/50 distance/near light distribution. The AcrySof IQ ReSTOR SN6AD1is an acrylic single-piece aspheric diffractive lens. The power of the add is +3.00 D with a 65/35 light distribution.

Official Title
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Effect of Presbyopic Correction Lens on Humphrey Visual Field Testing in Patients With Multifocal Intraocular Lens

Conditions
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Glaucoma, Cataract Senile

Intervention / Treatment
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* Diagnostic Test: Humphrey visual field testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Glaucomatous and non-glaucomatous patients Age older than 18 years A history of uneventful phacoemulsification with MIOL implantation at least one month before participation Distant best-corrected visual acuity (BCVA) equal to or better than 20/30 Near BCVA of at least Jaeger 2 Exclusion Criteria: The inability to perform reliable visual field testing (fixation loss, false positive or false negative more than 25%) A history of postoperative complications Moderate to advanced visual field defects (MD less than - 6 dB) Any other concurrent ocular diseases, except well-controlled glaucoma.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomized, prospective comparative study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glaucomatous arm<br>Mild stage glaucomatous patients age more than 18 years old, a history of uneventful phacoemulsification with MIOL implantation at least 1 month before participation, distant best-corrected visual acuity (BCVA) equal to or better than 20/30, near BCVA at least Jaeger 2. | Diagnostic Test: Humphrey visual field testing<br>* Perimetry was performed with the Humphrey Field Analyzer (Carl Zeiss Meditec Inc). Participants performed a 30-2 or a 24-2 Swedish Interactive Threshold Algorithm (SITA) standard test with stimulus size III, and standard Humphrey background luminance of 31.5 apostilbs. The participants were selected by simple random sampling to perform the HVF test with presbyopic collection lenses followed by without presbyopic collection lenses, or without presbyopic collection lenses followed by with presbyopic collection lenses. The power of presbyopic correction lens at the testing distance of 33 cm (the bowl radius) was auto-calculated according to the recommendation by the Humphrey Field Analyzer's manufacturer, depending on the current refractive error and the patient's age.<br>|
| Active Comparator: Non-glaucomatous arm<br>Pseudophakic participants without glaucoma, age more than 18 years old, a history of uneventful phacoemulsification with MIOL implantation at least 1 month before participation, distant best-corrected visual acuity (BCVA) equal to or better than 20/30, near BCVA at least Jaeger 2. | Diagnostic Test: Humphrey visual field testing<br>* Perimetry was performed with the Humphrey Field Analyzer (Carl Zeiss Meditec Inc). Participants performed a 30-2 or a 24-2 Swedish Interactive Threshold Algorithm (SITA) standard test with stimulus size III, and standard Humphrey background luminance of 31.5 apostilbs. The participants were selected by simple random sampling to perform the HVF test with presbyopic collection lenses followed by without presbyopic collection lenses, or without presbyopic collection lenses followed by with presbyopic collection lenses. The power of presbyopic correction lens at the testing distance of 33 cm (the bowl radius) was auto-calculated according to the recommendation by the Humphrey Field Analyzer's manufacturer, depending on the current refractive error and the patient's age.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean deviation | Mean deviation from Humphrey visual field testing | at 1 day after enrollment | 
| Pattern standard deviation | Pattern standard deviation from Humphrey visual field testing | at 1 day after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fixation loss (percent) | Fixation loss from Humphrey visual field testing | at 1 day after enrollment | 
| False negative (percent) | False negative from Humphrey visual field testing | at 1 day after enrollment | 
| False positive (percent) | False positive from Humphrey visual field testing | at 1 day after enrollment | 
| Test duration (minutes0 | Test duration from Humphrey visual field testing | at 1 day after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multifocal intraocular lens, presbyopia, cataract surgery, cataract, glaucoma