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

Sponsor

Siriraj Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05220007

Collaborator

(none)

Enrollment

Location

Arms

149

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Cataract Senile	Diagnostic Test: Humphrey visual field testing	N/A

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Non-randomized, prospective comparative studyNon-randomized, prospective comparative study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jul 31, 2012

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glaucomatous arm 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 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.
Active Comparator: Non-glaucomatous arm 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 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.

Arm

Intervention/Treatment

Experimental: Glaucomatous arm

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

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.

Active Comparator: Non-glaucomatous arm

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

Outcome Measures

Primary Outcome Measures

Mean deviation [at 1 day after enrollment]
Mean deviation from Humphrey visual field testing
Pattern standard deviation [at 1 day after enrollment]
Pattern standard deviation from Humphrey visual field testing

Secondary Outcome Measures

Fixation loss (percent) [at 1 day after enrollment]
Fixation loss from Humphrey visual field testing
False negative (percent) [at 1 day after enrollment]
False negative from Humphrey visual field testing
False positive (percent) [at 1 day after enrollment]
False positive from Humphrey visual field testing
Test duration (minutes0 [at 1 day after enrollment]
Test duration from Humphrey visual field testing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.