Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM (MFIOL)

Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM (Evolución clínica de Lente Intraocular Multifocal: OPTIVIS.TM)

This study evaluated visual outcome after cataract surgery with bilateral implantation of either a diffractive - refractive (hybrid) multifocal intraocular lens (MFIOL) or monofocal intraocular lens (IOL) as a control grup.

Study Overview

• Status: Completed
• Conditions: Cataract Senile; Lenses, Intraocular
• Intervention / Treatment: Device: OptiVis, Aaren Scientific; Device: Monofocal IOL

Detailed Description

PURPOSE: To present the outcomes of hybrid multifocal and monofocal intraocular lenses (IOL)

SETTING: Parc de Salut Mar, Universidad Pompeu-Fabra - Autónoma, Barcelona, Spain.

DESIGN: Prospective clinical trial.

METHODS: Consecutive patients with bilateral cataract were included. Phacoemulsification with randomized implantation of either a monofocal IOL (AR40e, AMO-Abbot 30 Laboratories Inc. Abbot Park, Illinois, USA) or multifocal IOL (OptiVis™, Aaren Scientific, Inc, Ontario, CA, USA) was performed by the same surgeon and under the same conditions. Over a 3-month follow-up, the main outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity at 60 cm (UIVA), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity at 33 cm (UNVA), distance-corrected near visual acuity (DCNVA), spherical equivalent (SE), contrast sensitivity (CS), presence of dysphotopsia, use of spectacles and patient satisfaction with the test VF-14 (Visual Function Index) .

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• senile cataract with Snellen visual acuity ≤ 0.5,
• motivation for spectacle independence for near vision (as the study was conducted in Spanish public health care system, entering study was the only option to get multifocal lens, as they are not provided by public health care, and the patients were conscious of the possibility of randomization to monofocal group.)

Exclusion Criteria:

• corneal astigmatism ≥ 1.10 diopters (D) and irregular astigmatism,
• axial length < 21.5 or ≥ 25 mm,
• pupillary diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm,
• ocular pathology that could affect the visual function and/or intraocular lens centering and intraoperative or postoperative complications.
• highly demanding patients and those whose profession could be affected by a multifocal design (professional drivers, jewelers etc.) were also excluded (as in the Spanish public health care system secondary procedures needed to satisfy patients' expectation, such as LRI´s, LASIK, PRK´s, are not available).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multifocal IOL (OptiVis); Ambulatory surgery was performed by the same, experienced surgeon, under topical anesthesia, using as a technique phacoemulsification with small incision (2.75) in clear cornea in the most curved meridian. The randomly assigned IOL (in this arm: a hybrid (refractive-diffractive) multifocal IOL (OptiVis, Aaren Scientific) was implanted in the capsular bag. The second eye with the same type of lens of the first eye was operated within 2-4 weeks.	Device: OptiVis, Aaren Scientific; All the surgeries were performed under topical anesthesia using a standard phacoemulsification procedure with Infiniti Vision System (all from Alcon Laboratories, Inc, Fort Worth, TX).; Other Names: a hybrid multifocal intraocular lens
Active Comparator: Monofocal IOL; Ambulatory surgery was performed by the same, experienced surgeon, under topical anesthesia, using as a technique phacoemulsification with small incision (2.75) in clear cornea in the most curved meridian. The randomly assigned IOL (in this arm: a monofocal IOL (AR40e, AMO) was implanted in the capsular bag. The second eye with the same type of lens of the first eye was operated within 2-4 weeks.	Device: Monofocal IOL; All the surgeries were performed under topical anesthesia using a standard phacoemulsification procedure with Infiniti Vision System (all from Alcon Laboratories, Inc, Fort Worth, TX).; Other Names: AR40e, AMO-Abbot 30 Laboratories Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual function	Changes in visual acuity in logMAR: uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) at 6 m, uncorrected intermediate visual acuity (UIVA), distance-corrected intermediate visual acuity (DCIVA) at 60 cm (in the OptiVis group only, as they were supposed to provide intermediate distance vision in contrary to monofocal lenses), uncorrected near visual acuity (UNVA) and distance-corrected near visual acuity (DCNVA) at 33 cm. All measured using Snellen acuity charts under photopic conditions.	The last follow-up visit (3 months after the surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity (CS)	Changes in monocular and binocular CS were measured in mesopic conditions, without glare at spatial frequencies of 1.5, 3, 6, 12 and 18 cycles per degree (cpd) using the Functional Acuity Contrast Test (FACT, OPTEC 6500®, Stereo Optical Co. Inc)	The last follow-up visit (3 months after the surgery)
Refractive Outcomes	The predictability of the refractive outcome. Postoperative spherical equivalent (SE) and SE within ±0.50 D of the attempted spherical correction (emmetropy) and within ±1.00 D of the attempted spherical correction (emmetropy).	The last follow-up visit (3 months after the surgery)
Spectacle dependence	Spectacle dependence, determined by questionnaire (Do you wear glasses for distance/near vision?).	The last follow-up visit (3 months after the surgery)
Presence of dysphotopsia	Presence of dysphotopsia (halos, glare), spontaneously mentioned or elicited in response to questioning were determined by questionnaire.	The last follow-up visit (3 months after the surgery)
Patient satisfaction	Patient satisfaction was also assessed with the VF-14 test, consisting of 14 questions evaluating various patient activities.	The last follow-up visit (3 months after the surgery)

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Investigators: Principal Investigator: Ana Martinez Palmer, PhD, Parc de Salut Mar, Barcelona, Spain

Publications and helpful links

General Publications

• Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD003169. doi: 10.1002/14651858.CD003169.pub3.
• de Vries NE, Nuijts RM. Multifocal intraocular lenses in cataract surgery: literature review of benefits and side effects. J Cataract Refract Surg. 2013 Feb;39(2):268-78. doi: 10.1016/j.jcrs.2012.12.002.
• de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4.
• Cochener B, Lafuma A, Khoshnood B, Courouve L, Berdeaux G. Comparison of outcomes with multifocal intraocular lenses: a meta-analysis. Clin Ophthalmol. 2011 Jan 7;5:45-56. doi: 10.2147/OPTH.S14325.
• Piovella M, Bosc JM. Clinical evaluation of the OptiVis multifocal intraocular lens. Adv Ther. 2011 Nov;28(11):1012-20. doi: 10.1007/s12325-011-0064-7. Epub 2011 Oct 31.
• Dyrda A, Martinez-Palmer A, Martin-Moral D, Rey A, Morilla A, Castilla-Marti M, Arones-Santivanez J. Clinical Results of Diffractive, Refractive, Hybrid Multifocal, and Monofocal Intraocular Lenses. J Ophthalmol. 2018 Jun 25;2018:8285637. doi: 10.1155/2018/8285637. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2014
• Primary Completion (Actual): June 4, 2015
• Study Completion (Actual): June 4, 2015

Study Registration Dates

• First Submitted: April 8, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: presbyopia; multifocal intraocular lens; OptiVis; hybrid multifocal intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2013/5432/I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: The data are available now as the conducted study was finished and until the publication will be in press. After that all data will be available via journal requests
• IPD Sharing Access Criteria: Requesters will be required to sign a Data Access Agreement
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes