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CompletedNCT04972435Updated Jul 30, 2021

Effect of Multifocal Intraocular Lens on Contrast Sensitivity in Primary Angle-Closure Patients

An interventional study of Contrast sensitivity in Primary Angle Closure Glaucoma, Primary Angle Glaucoma Closure Suspect and Senile Cataract, sponsored by Siriraj Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-30.

Sponsored by Siriraj Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 6 months after the study started (first participant enrolled Jan 2014, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This prospective study included patients with primary angle-closure (PAC or primary angle-closure glaucoma (PACG) and visually significant cataract. Phacoemulsification with multifocal intraocular lens (MIOL) or monofocal IOL (mIOL) (patient preference) was performed. Collected data included best-corrected distant visual acuity (BCVA), intraocular pressure (IOP), anterior chamber depth (ACD), and contrast sensitivity (CS) measured at spatial frequency 1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree (CPD) preoperatively, and at 2-6 months postoperatively. Preoperative and postoperative parameters were compared to evaluate the effect of MIOL on CS in eyes with PAC or PACG.

Read the detailed description

This prospective non-randomized clinical study was conducted at the Department of Ophthalmology of the Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand during January 2014 to December 2015. The study protocol and informed consent procedures were both approved by our center's institutional review board (IRB) (approval number Si 384/2014). Each patient provided written informed consent prior to participation.

Primary angle closure was defined as an eye with invisible non-pigmented trabecular meshwork greater than 180 degrees and evidence of peripheral anterior synechiae on gonioscopy without glaucomatous optic disc appearance, glaucomatous pattern visual field damage, or history of increased IOP. Primary angle closure glaucoma was defined as an eye with invisible non-pigmented trabecular meshwork greater than 180 degrees on gonioscopy with glaucomatous optic damage (cup-to-disc ratio greater than 0.5 and/or localized neuro-retinal rim defect) and history of increased IOP raising. Patients with PACG must have been under good disease control, which was defined as IOP under 20 mmHg with 1 to 3 topical anti-glaucoma medications without deterioration of visual field, except generalized depression from cataract. Intra-ocular lens calculation was performed at the baseline visit using IOL Master. All patients received information about the advantages and disadvantages of MIOLs (Tecnis ZMB00 or Acrysof IQ Restore SN6AD1) and of mIOLs (Tecnis ZCB00 or Acrysof IQ SN60WF) before choosing the type of IOL that they individually preferred. Cataract surgery was performed by a single surgeon. Topical anesthesia was applied before standard phacoemulsification (2.2 mm temporal clear cornea incision and continuous curvilinear capsulorhexis) and IOL implantation into the capsular bag. Eyes with any intraoperative or postoperative complication were excluded.

Data specific to uncorrected and best-corrected distant visual acuities (UCVA and BCVA) in logMar, auto-refraction, slit-lamp ophthalmoscopic examination, intraocular pressure (IOP) measurement with Goldmann applanation tonometry, contrast sensitivity (CS), anterior chamber depth (ACD), central corneal thickness (CCT), and axial length (AL) were collected on the preoperative screening day, and at the 2 to 6-month postoperative follow-up. CS was measured under normal room light (photopic) conditions to evaluate patient quality of vision during the performance of their daily activities using a Functional Vision Analyzer. This test produces sine-wave gratings of different spatial frequencies. The absolute values of distance CS were obtained at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree; CPD). Visante® AS-OCT was used to determine CCT and ACD. ACD was defined as the distance between the corneal endothelium and the anterior surface of the crystalline lens (preoperative) or iris plane (postoperative). Axial length was obtained using IOL Master.

Comparisons of continuous data with normal distribution were made using Student's t-test for unpaired data, and using Mann-Whitney U test for non-normally distributed data. A p-value of less than 0.05 was defined as denoting statistical significance.

02

Conditions studied

  • Primary Angle Closure Glaucoma
  • Primary Angle Glaucoma Closure Suspect
  • Senile Cataract

Keywords

  • primary angle closure
  • primary angle closure glaucoma
  • cataract surgery
  • contrast sensitivity
  • intraocular lens
03

In context

Glaucoma, Angle-Closure

91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.

This study's enrollment of 35 is below the median of 57 across 58 interventional studies indexed under Glaucoma, Angle-Closure.

Browse Glaucoma, Angle-Closure studies →

Lead sponsor

Siriraj Hospital is the lead sponsor of 95 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Visually significant cataract patients aged >18 years with PAC or PACG who underwent prophylaxis peripheral iridotomy at least 2 months prior to participation.

Exclusion criteria

Exclusion Criteria:

  • Patients with preexisting glaucomatous visual field defect, except generalized depression
  • Any other concurrent ocular diseases that could affect visual acuity, except cataract
  • History of ocular inflammation or ocular surgery, except laser peripheral iridotomy, which is a routine procedure for treating PAC/PACG
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Multifocal intraocular lens group

    Cataract patients with PAC or PACG who underwent phacoemulsification with multifocal intraocular lens implantation.

    Diagnostic Test: Contrast sensitivity

  • Sham comparator
    Monofocal intraocular lens group

    Cataract patients with PAC or PACG who underwent phacoemulsification with monofocal intraocular lens implantation which are the standard IOL.

    Diagnostic Test: Contrast sensitivity

Interventions

  • Diagnostic testContrast sensitivity

    All subjects performed the contrast sensitivity measurement preoperatively and one time at 2 months postoperatively.

06

What researchers measure

Primary outcomes

  1. Contrast sensitivity

    Contrast sensitivity at partial frequency 1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree (CPD)

    Time frame: Preoperative (on screening day)

  2. Contrast sensitivity

    Contrast sensitivity at partial frequency 1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree (CPD)

    Time frame: At 2nd month postoperatively

Secondary outcomes

  1. Visual acuity

    Visual acuity at distance in LogMar

    Time frame: Preoperative (on screening day)

  2. Visual acuity

    Visual acuity at distance in LogMar

    Time frame: At 2nd month postoperatively

  3. Anterior chamber depth

    Anterior chamber depth

    Time frame: Preoperative (on screening day)

  4. Anterior chamber depth

    Anterior chamber depth

    Time frame: At 2nd month postoperatively

07

Study locations

1 site
  • Naris Kitnarong
    Bangkoknoi, Bangkok 10700, Thailand
08

References and documents

Publications

  • Teichman JC, Ahmed II. Intraocular lens choices for patients with glaucoma. Curr Opin Ophthalmol. 2010 Mar;21(2):135-43. doi: 10.1097/ICU.0b013e3283365154. PubMed 20040877 ↗
  • Kim CY, Chung SH, Kim TI, Cho YJ, Yoon G, Seo KY. Comparison of higher-order aberration and contrast sensitivity in monofocal and multifocal intraocular lenses. Yonsei Med J. 2007 Aug 31;48(4):627-33. doi: 10.3349/ymj.2007.48.4.627. PubMed 17722234 ↗
  • 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 ↗
  • Montes-Mico R, Alio JL. Distance and near contrast sensitivity function after multifocal intraocular lens implantation. J Cataract Refract Surg. 2003 Apr;29(4):703-11. doi: 10.1016/s0886-3350(02)01648-6. PubMed 12686237 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2014 to primary completion in Dec 2015, 23 months.

Of 28 interventional studies with no phase under Glaucoma, Angle-Closure, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 43. This study's 23 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2021
First posted
Jul 22, 2021
StartActual
Jan 2, 2014
Primary completionActual
Dec 30, 2015
CompletionActual
Dec 30, 2015
Last update
Jul 30, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04972435
Lead sponsor
Siriraj Hospital
Responsible party
Naris Kitnarong (Associate professor, Siriraj Hospital) — Principal investigator
First posted
Jul 22, 2021
Start date
Jan 2, 2014
Primary completion
Dec 30, 2015
Completion
Dec 30, 2015
Last update
Jul 30, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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