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

Not Applicable

Completed

• Conditions: Cataract Senile; Glaucoma
• Interventions: Diagnostic Test: Humphrey visual field testing

• Registration Number: NCT05220007
• Lead Sponsor: Siriraj Hospital

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 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 Timeline

• Study Start: 2009-06-01
• Primary Completion: 2012-07-31
• Study Completion: 2021-10-31
• Study First Submitted: 2021-12-27
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-28
• Last Update Submitted: 2022-01-28
• Study First Posted: 2022-02-02
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glaucomatous arm	Humphrey visual field testing	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.
Non-glaucomatous arm	Humphrey visual field testing	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.

Primary Outcome Measures

Name	Time	Method
Pattern standard deviation	at 1 day after enrollment	Pattern standard deviation from Humphrey visual field testing
Mean deviation	at 1 day after enrollment	Mean deviation from Humphrey visual field testing

Secondary Outcome Measures

Name	Time	Method
False negative (percent)	at 1 day after enrollment	False negative from Humphrey visual field testing
Fixation loss (percent)	at 1 day after enrollment	Fixation loss 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

Trial Locations

Locations (1)

Naris Kitnarong; 🇹🇭 Bangkoknoi, Bangkok, Thailand