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The Incidence of Glistenings in the 2017 Intraocular Lenses Made by Alcon and Abbott Medical Optics

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ClinicalTrials.gov Identifier: NCT03409185
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Kensington Eye Institute
Information provided by (Responsible Party):
Yaping Jin, University of Toronto

Brief Summary:
The purpose of this study is to seek academic/non-industry research funding support to independently investigate the incidence and density of lens glistenings in cataract patients who are implanted with the latest generations of intraocular lenses (IOL) manufactured by Alcon and AMO Medical Optics.

Condition or disease Intervention/treatment Phase
Cataracts Visual Acuity Reduced Transiently Loss of Visual Contrast Sensitivity Functional Visual Loss Device: Alcon 1 piece SA60AT lens Device: AMO 1-piece AABOO lens Not Applicable

Detailed Description:

Glistenings are tiny, clear sparkling, fluid-filled microvacuoles that form within a lens after it has been placed in the eye. Glistenings are seen in all lenses but certain lenses develop a higher number of glistenings than others. The effect of glistenings on patients' visual functioning is largely unknown.

The occurrence of glistenings is in part related to the manufacturing technique. In 2013, manufacturers have claimed that recent improvements in manufacturing process have reduced the occurrence of glistenings. There is a lack of independent evaluation of this claim. We would like to assess independently: 1) How frequently do glistenings occur in patients implanted with the 2015 generation lenses? 2) Is there a difference in glistening occurrence between lenses manufactured by Alcon and Abbott Medical Optics (AMO) - the two largest companies in eye care products?

Two-hundred and seventy-six patients will be randomly assigned to receive Alcon or AMO lenses for their cataract surgery at the Kensington Eye Institute (KEI). After surgery, patients will be instructed to return for follow-up visits at 1 month, 6 months, 12 months and 18 months to assess for the occurrence of glistenings. If glistenings are observed at an earlier follow-up visit (e.g., the 6 month visit), patients will still be instructed to come for future visits so that changes in the glistenings over time can be observed.

Project Time-line:

Months 1-8: Participants recruiting, surgical operations, follow-up visits. Months 9-24: follow-up visits, data entry, cleaning and analysis, early results presentation, manuscript preparation and final report.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Incidence of Glistenings in the 2017 Generation of Hydrophobic Acrylic Lenses Manufactured by Alcon and Abbott Medical Optics
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Alcon lens group
Alcon 1 piece SA60AT lens
Device: Alcon 1 piece SA60AT lens
Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-absorbing Acrylate/Methacrylate Copolymer

Active Comparator: AMO lens group
AMO 1 piece Sensar AABOO lens
Device: AMO 1-piece AABOO lens
Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-blocking hydrophobic acrylic




Primary Outcome Measures :
  1. Incidence and density (severity) of glistenings at 18-month follow-up visit [ Time Frame: 18-month follow-up ]

    To determine if glistenings develop, eyes are dilated and examined. Photographs of the IOLs will be taken with a slit lamp camera for documentation. These photographs will then be assessed for glistenings in two ways: first by trained ophthalmology staff, and second using the ImageJ software

    Glistenings will be counted and graded on a scale of 0 to 5+ as following:

    0. No glistening

    1. Less than 10 glistenings
    2. 10 to 25 glistenings
    3. 25 to 50 glistenings
    4. 50 to 100 glistenings
    5. Greater than 100 glistenings


Secondary Outcome Measures :
  1. Visual acuity in eyes with glistenings at 18-month follow-up visit [ Time Frame: 18 month follow-up ]
    Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart.

  2. Contrast sensitivity in eyes with glistenings at 18-month follow-up visit [ Time Frame: 18 month follow-up ]
    Contrast sensitivity: the ability of the visual system to distinguish between an object and its background. This will be tested with the Vector Vision CSV-1000HGT.

  3. Glare disability in eyes with glistenings at 18-month follow-up visit [ Time Frame: 18 month follow-up ]
    Glare disability: the difficulty seeing in the presence of very bright light such as night-time lighting or sunshine. This will be tested using the Brightness Acuity Tester (BAT).

  4. Visual acuity in eyes with glistenings at 12-month follow-up visit [ Time Frame: 12-month follow-up ]
    Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart

  5. Contrast sensitivity and glare disability in eyes with glistenings at 12-month follow-up visit [ Time Frame: 12-month follow-up ]
    Contrast sensitivity: the ability of the visual system to distinguish between an object and its background. This will be tested with the Vector Vision CSV-1000HGT.

  6. Glare disability in eyes with glistenings at 12-month follow-up visit [ Time Frame: 12-month follow-up ]
    Glare disability: the difficulty seeing in the presence of very bright light such as night-time lighting or sunshine. This will be tested using the Brightness Acuity Tester (BAT).

  7. Visual acuity in eyes with glistenings at 6-month follow-up visit [ Time Frame: 6-month follow-up ]
    Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart.

  8. Contrast sensitivity in eyes with glistenings at 6-month follow-up visit [ Time Frame: 6-month follow-up ]
    Contrast sensitivity: the ability of the visual system to distinguish between an object and its background. This will be tested with the Vector Vision CSV-1000HGT.

  9. Glare disability in eyes with glistenings at 6-month follow-up visit [ Time Frame: 6-month follow-up ]
    Glare disability: the difficulty seeing in the presence of very bright light such as night-time lighting or sunshine. This will be tested using the Brightness Acuity Tester (BAT).

  10. Incidence of glistenings at 12-month follow-up visit [ Time Frame: 12-month follow-up ]

    To determine if glistenings develop, eyes are dilated and examined. Photographs of the IOLs will be taken with a slit lamp camera for documentation. These photographs will then be assessed for glistenings in two ways: first by trained ophthalmology staff, and second using the ImageJ software

    Glistenings will be counted and graded on a scale of 0 to 5+ as following:

    0. No glistening

    1. Less than 10 glistenings
    2. 10 to 25 glistenings
    3. 25 to 50 glistenings
    4. 50 to 100 glistenings
    5. Greater than 100 glistenings

  11. Incidence of glistenings at 6-month follow-up visit [ Time Frame: 6-month follow-up ]

    To determine if glistenings develop, eyes are dilated and examined. Photographs of the IOLs will be taken with a slit lamp camera for documentation. These photographs will then be assessed for glistenings in two ways: first by trained ophthalmology staff, and second using the ImageJ software

    Glistenings will be counted and graded on a scale of 0 to 5+ as following:

    0. No glistening

    1. Less than 10 glistenings
    2. 10 to 25 glistenings
    3. 25 to 50 glistenings
    4. 50 to 100 glistenings
    5. Greater than 100 glistenings



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients consulting 5 surgeons for cataract surgery in the surgeon's primary offices
  • Patients aged 18 years or older
  • Patients who signed the consent form

Exclusion Criteria:

  • Individuals who cannot understand English in either written or verbal form and do not have language assistance available (e.g. from family members, friends)
  • Patients with co-existing condition of corneal disease
  • Patients with co-existing condition of uveitis
  • Patients with co-existing condition of optic nerve disease
  • Patients with co-existing condition of macular disease
  • Patients with co-existing condition of diabetes
  • Patients with co-existing condition of severe glaucoma (i.e. C/D ratio >=0.9 AND the patient is on glaucoma treatment)
  • Patients with prior refractive surgery
  • Patients with complications of cataract surgery occurred during or after surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409185


Contacts
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Contact: Sherif El-Defrawy, MD, FRCSC 416-978-7931 seldefrawy@KensingtonHealth.org
Contact: Yaping Jin, MD, PhD 416-978-7938 Yaping.Jin@utoronto.ca

Locations
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Canada, Ontario
Kensington Eye Institute Recruiting
Toronto, Ontario, Canada, M5T3A9
Contact: Yaping Jin, MD, PhD    1-416-978-7938    Yaping.Jin@utoronto.ca   
Sponsors and Collaborators
University of Toronto
Kensington Eye Institute
Investigators
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Principal Investigator: Sherif El-Defrawy, MD, FRCSC University of Toronto
Principal Investigator: Yaping Jin, MD, PhD University of Toronto

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Responsible Party: Yaping Jin, Associate Professor in Ophthalmic Epidemiology, University of Toronto
ClinicalTrials.gov Identifier: NCT03409185     History of Changes
Other Study ID Numbers: 108162330RR0001
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Yaping Jin, University of Toronto:
Cataract surgery
Intraocular lens
Glistenings

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Dipivefrin
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs