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

NCT04972435 | Completed DMC

• 1 other identifier: Naris001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Contrast sensitivity

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

  Preoperative (on screening day)

• Contrast sensitivity

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

  At 2nd month postoperatively

Secondary Outcomes (4)

• Visual acuity

  Preoperative (on screening day)

• Visual acuity

  At 2nd month postoperatively

• Anterior chamber depth

  Preoperative (on screening day)

• Anterior chamber depth

  At 2nd month postoperatively

Study Arms (2)

Multifocal intraocular lens group

EXPERIMENTAL

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

Diagnostic Test: Contrast sensitivity

Monofocal intraocular lens group

SHAM COMPARATOR

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

Diagnostic Test: Contrast sensitivity

Interventions

Contrast sensitivity DIAGNOSTIC_TEST

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

Monofocal intraocular lens group; Multifocal intraocular lens group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Naris Kitnarong

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (4)

• 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.

  PMID: 20040877 RESULT

• 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.

  PMID: 17722234 RESULT

• 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.

  PMID: 17159450 RESULT

• 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.

  PMID: 12686237 RESULT

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Contrast Sensitivity

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Visual Acuity; Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Cataract patients with PAC or PACG who schedule for phacoemulsification with intraocular lens implantation. The patients must decide preoperatively to use multifocal IOL or monofocal IOL (patient preference) after receiving clear information about those 2 IOL models. Postoperatively, the contrast sensitivity (CS)will be measured with the same method. The postoperative CS were compared between groups.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: January 2, 2014
• Primary Completion: December 30, 2015
• Study Completion: December 30, 2015
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)