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Completed

NCT Number: NCT04972435

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naris Kitnarong

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Contrast sensitivity

Diagnostic Test

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

Primary outcomes

  1. Contrast sensitivity

    Time frame: Preoperative (on screening day)

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

  2. Contrast sensitivity

    Time frame: At 2nd month postoperatively

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

Secondary outcomes

  1. Visual acuity

    Time frame: Preoperative (on screening day)

    Visual acuity at distance in LogMar

  2. Visual acuity

    Time frame: At 2nd month postoperatively

    Visual acuity at distance in LogMar

  3. Anterior chamber depth

    Time frame: Preoperative (on screening day)

    Anterior chamber depth

  4. Anterior chamber depth

    Time frame: At 2nd month postoperatively

    Anterior chamber depth

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2021
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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