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

Sponsor
Parc de Salut Mar (Other)
Overall Status
Completed
CT.gov ID
NCT03512626
Collaborator
(none)
32
2
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: OptiVis, Aaren Scientific
  • Device: Monofocal IOL
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM (Evolución clínica de Lente Intraocular Multifocal: OPTIVIS.TM)
Actual Study Start Date :
Jun 4, 2014
Actual Primary Completion Date :
Jun 4, 2015
Actual Study Completion Date :
Jun 4, 2015

Arms and Interventions

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.
  • Outcome Measures

    Primary Outcome Measures

    1. Visual function [The last follow-up visit (3 months after the surgery)]

      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

    1. Contrast sensitivity (CS) [The last follow-up visit (3 months after the surgery)]

      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)

    2. Refractive Outcomes [The last follow-up visit (3 months after the surgery)]

      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).

    3. Spectacle dependence [The last follow-up visit (3 months after the surgery)]

      Spectacle dependence, determined by questionnaire (Do you wear glasses for distance/near vision?).

    4. Presence of dysphotopsia [The last follow-up visit (3 months after the surgery)]

      Presence of dysphotopsia (halos, glare), spontaneously mentioned or elicited in response to questioning were determined by questionnaire.

    5. Patient satisfaction [The last follow-up visit (3 months after the surgery)]

      Patient satisfaction was also assessed with the VF-14 test, consisting of 14 questions evaluating various patient activities.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Parc de Salut Mar

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    ANNA MARTÍNEZ PALMER, Head of Ophthalmology Department, Parc de Salut Mar
    ClinicalTrials.gov Identifier:
    NCT03512626
    Other Study ID Numbers:
    • 2013/5432/I
    First Posted:
    May 1, 2018
    Last Update Posted:
    May 1, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by ANNA MARTÍNEZ PALMER, Head of Ophthalmology Department, Parc de Salut Mar
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 1, 2018