Clinical trial NCT05220007: Effect of Presbyopic Correction Lens on Humphrey Visual Field Testing in Patients With Multifocal Intraocular Lens
Official title: Effect of Presbyopic Correction Lens on Humphrey Visual Field Testing in Patients With Multifocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Cataract Senile
Keywords: cataract
glaucoma
multifocal intraocular lens
presbyopia
cataract surgery
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized, prospective comparative study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean deviation
timeFrame: at 1 day after enrollment
measure: Pattern standard deviation
timeFrame: at 1 day after enrollment
Secondary outcomes:
measure: Fixation loss (percent)
timeFrame: at 1 day after enrollment
measure: False negative (percent)
timeFrame: at 1 day after enrollment
measure: False positive (percent)
timeFrame: at 1 day after enrollment
measure: Test duration (minutes0
timeFrame: at 1 day after enrollment
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Naris Kitnarong
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Naris Kitnarong, M.D., M.B.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aychoua N, Junoy Montolio FG, Jansonius NM. Influence of multifocal intraocular lenses on standard automated perimetry test results. JAMA Ophthalmol. 2013 Apr;131(4):481-5. doi: 10.1001/jamaophthalmol.2013.2368.
citation: Farid M, Chak G, Garg S, Steinert RF. Reduction in mean deviation values in automated perimetry in eyes with multifocal compared to monofocal intraocular lens implants. Am J Ophthalmol. 2014 Aug;158(2):227-231.e1. doi: 10.1016/j.ajo.2014.04.017. Epub 2014 Apr 29.
citation: Yohannan J, Wang J, Brown J, Chauhan BC, Boland MV, Friedman DS, Ramulu PY. Evidence-based Criteria for Assessment of Visual Field Reliability. Ophthalmology. 2017 Nov;124(11):1612-1620. doi: 10.1016/j.ophtha.2017.04.035. Epub 2017 Jul 1.
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.