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

Primary Purpose

Glaucoma, Cataract Senile

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Humphrey visual field testing
Sponsored by
Siriraj Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring cataract, glaucoma, multifocal intraocular lens, presbyopia, cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Naris Kitnarong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glaucomatous arm

Non-glaucomatous arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean deviation
Mean deviation from Humphrey visual field testing
Pattern standard deviation
Pattern standard deviation from Humphrey visual field testing

Secondary Outcome Measures

Fixation loss (percent)
Fixation loss from Humphrey visual field testing
False negative (percent)
False negative from Humphrey visual field testing
False positive (percent)
False positive from Humphrey visual field testing
Test duration (minutes0
Test duration from Humphrey visual field testing

Full Information

First Posted
December 27, 2021
Last Updated
January 28, 2022
Sponsor
Siriraj Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05220007
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2009 (Actual)
Primary Completion Date
July 31, 2012 (Actual)
Study Completion Date
October 31, 2021 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Cataract Senile
Keywords
cataract, glaucoma, multifocal intraocular lens, presbyopia, cataract surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomized, prospective comparative study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glaucomatous arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-glaucomatous arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Humphrey visual field testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean deviation
Description
Mean deviation from Humphrey visual field testing
Time Frame
at 1 day after enrollment
Title
Pattern standard deviation
Description
Pattern standard deviation from Humphrey visual field testing
Time Frame
at 1 day after enrollment
Secondary Outcome Measure Information:
Title
Fixation loss (percent)
Description
Fixation loss from Humphrey visual field testing
Time Frame
at 1 day after enrollment
Title
False negative (percent)
Description
False negative from Humphrey visual field testing
Time Frame
at 1 day after enrollment
Title
False positive (percent)
Description
False positive from Humphrey visual field testing
Time Frame
at 1 day after enrollment
Title
Test duration (minutes0
Description
Test duration from Humphrey visual field testing
Time Frame
at 1 day after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naris Kitnarong, M.D., M.B.A.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
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
23430147
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.
Results Reference
result
PubMed Identifier
24784872
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.
Results Reference
result
PubMed Identifier
28676280
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.
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

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

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