Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM

NCT03512626 | Completed FDA Device

• 1 other identifier: 2013/5432/I
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cataract Senile; Lenses, Intraocular

Keywords

OptiVis; hybrid multifocal intraocular lens; multifocal intraocular lens; presbyopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Contrast sensitivity (CS)

  The last follow-up visit (3 months after the surgery)

• Refractive Outcomes

  The last follow-up visit (3 months after the surgery)

• Spectacle dependence

  The last follow-up visit (3 months after the surgery)

• Presence of dysphotopsia

  The last follow-up visit (3 months after the surgery)

• Patient satisfaction

  The last follow-up visit (3 months after the surgery)

Study Arms (2)

Multifocal IOL (OptiVis)

EXPERIMENTAL

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

Monofocal IOL

ACTIVE COMPARATOR

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

Interventions

OptiVis, Aaren Scientific DEVICE

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).

Also known as: a hybrid multifocal intraocular lens

Multifocal IOL (OptiVis)

Monofocal IOL DEVICE

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).

Also known as: AR40e, AMO-Abbot 30 Laboratories Inc.

Monofocal IOL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Parc de Salut Mar: lead

Related Publications (6)

• 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.

  PMID: 27943250 BACKGROUND

• 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.

  PMID: 21311656 BACKGROUND

• 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.

  PMID: 22057725 BACKGROUND

• 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.

  PMID: 22972061 BACKGROUND

• 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.

  PMID: 23332253 BACKGROUND

• 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.

  PMID: 30046464 DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Ana Martinez Palmer, PhD

  Parc de Salut Mar, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Model Details: Consecutive patients with bilateral cataract were included after meeting all the inclusion and none of exclusion criteria and when written informed consent was obtained from all patients. Patients were randomly assigned to have bilateral implantation with either a monofocal IOL (AR40e, AMO-Abbot 30 Laboratories Inc. Abbot Park, Illinois, USA) or multifocal IOL (OptiVis™, Aaren Scientific, Inc, Ontario, CA, USA).

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: May 1, 2018
• Study Start: June 4, 2014
• Primary Completion: June 4, 2015
• Study Completion: June 4, 2015
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• Access Criteria: Requesters will be required to sign a Data Access Agreement