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GlaucomaNCT05220007

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

A study testing Humphrey visual field testing in people with Glaucoma and Cataract Senile, run by Siriraj Hospital at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Glaucoma, Cataract Senile
What is being tested?
Humphrey visual field testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteThailand
Study dates
1 Jun 2009to 31 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Naris Kitnarong

    Bangkoknoi, Bangkok, 10700

Other trials in Thailand

About this study

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.

Read the 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.

Being tested
Humphrey visual field testing
Keywords
cataract, glaucoma, multifocal intraocular lens, presbyopia, cataract surgery
Medical subject headings
Glaucoma, Cataract, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Humphrey visual field testingDiagnostic test

    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.

Study groups in NCT05220007
Study groupRoleWhat they receive
Glaucomatous armExperimentalMild 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.
Receives: Diagnostic Test: Humphrey visual field testing
Non-glaucomatous armActive comparatorPseudophakic 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.
Receives: Diagnostic Test: Humphrey visual field testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean deviation

    Mean deviation from Humphrey visual field testing

    Measured: at 1 day after enrollment

  2. Pattern standard deviation

    Pattern standard deviation from Humphrey visual field testing

    Measured: at 1 day after enrollment

Secondary outcomes (4)

  1. Fixation loss (percent)

    Fixation loss from Humphrey visual field testing

    Measured: at 1 day after enrollment

  2. False negative (percent)

    False negative from Humphrey visual field testing

    Measured: at 1 day after enrollment

  3. False positive (percent)

    False positive from Humphrey visual field testing

    Measured: at 1 day after enrollment

  4. Test duration (minutes0

    Test duration from Humphrey visual field testing

    Measured: at 1 day after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start1 Jun 2009
  3. Primary completion31 Jul 2012
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Non-randomized, prospective comparative study
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220007
Sponsor's protocol ID
MIOLVF001
Status last verified
Jan 2022
First submitted
27 Dec 2021
Last updated
2 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23430147

  • 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.

    PubMed 24784872

  • 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.

    PubMed 28676280

  • 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.

    PubMed 17159450

Questions about this trial

What is this clinical trial studying?

A study testing Humphrey visual field testing in people with Glaucoma and Cataract Senile, run by Siriraj Hospital at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean deviation (time frame: at 1 day after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220007, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.

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