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

Primary Purpose

Cataract Senile, Lenses, Intraocular

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OptiVis, Aaren Scientific
Monofocal IOL
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Senile focused on measuring OptiVis, hybrid multifocal intraocular lens, multifocal intraocular lens, presbyopia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Multifocal IOL (OptiVis)

    Monofocal IOL

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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)
    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).
    Spectacle dependence
    Spectacle dependence, determined by questionnaire (Do you wear glasses for distance/near vision?).
    Presence of dysphotopsia
    Presence of dysphotopsia (halos, glare), spontaneously mentioned or elicited in response to questioning were determined by questionnaire.
    Patient satisfaction
    Patient satisfaction was also assessed with the VF-14 test, consisting of 14 questions evaluating various patient activities.

    Full Information

    First Posted
    April 8, 2018
    Last Updated
    April 18, 2018
    Sponsor
    Parc de Salut Mar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03512626
    Brief Title
    Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM
    Acronym
    MFIOL
    Official Title
    Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM (Evolución clínica de Lente Intraocular Multifocal: OPTIVIS.TM)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 4, 2014 (Actual)
    Primary Completion Date
    June 4, 2015 (Actual)
    Study Completion Date
    June 4, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Parc de Salut Mar

    4. Oversight

    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

    5. Study Description

    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.
    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) .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract Senile, Lenses, Intraocular
    Keywords
    OptiVis, hybrid multifocal intraocular lens, multifocal intraocular lens, presbyopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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).
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Multifocal IOL (OptiVis)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Monofocal IOL
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    OptiVis, Aaren Scientific
    Other Intervention Name(s)
    a hybrid multifocal intraocular lens
    Intervention Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    Monofocal IOL
    Other Intervention Name(s)
    AR40e, AMO-Abbot 30 Laboratories Inc.
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Visual function
    Description
    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.
    Time Frame
    The last follow-up visit (3 months after the surgery)
    Secondary Outcome Measure Information:
    Title
    Contrast sensitivity (CS)
    Description
    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)
    Time Frame
    The last follow-up visit (3 months after the surgery)
    Title
    Refractive Outcomes
    Description
    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).
    Time Frame
    The last follow-up visit (3 months after the surgery)
    Title
    Spectacle dependence
    Description
    Spectacle dependence, determined by questionnaire (Do you wear glasses for distance/near vision?).
    Time Frame
    The last follow-up visit (3 months after the surgery)
    Title
    Presence of dysphotopsia
    Description
    Presence of dysphotopsia (halos, glare), spontaneously mentioned or elicited in response to questioning were determined by questionnaire.
    Time Frame
    The last follow-up visit (3 months after the surgery)
    Title
    Patient satisfaction
    Description
    Patient satisfaction was also assessed with the VF-14 test, consisting of 14 questions evaluating various patient activities.
    Time Frame
    The last follow-up visit (3 months after the surgery)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana Martinez Palmer, PhD
    Organizational Affiliation
    Parc de Salut Mar, Barcelona, Spain
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    27943250
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21311656
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22057725
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22972061
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23332253
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30046464
    Citation
    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.
    Results Reference
    derived

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    Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM

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