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

December 1, 2023 updated by: Yaping Jin, University of Toronto

The Incidence of Glistenings in the 2017 Generation of Hydrophobic Acrylic Lenses Manufactured by Alcon and Abbott Medical Optics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T3A9
        • Kensington Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
18-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
18 month follow-up
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.
18 month follow-up
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).
18 month follow-up
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
12-month follow-up
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.
12-month follow-up
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).
12-month follow-up
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.
6-month follow-up
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.
6-month follow-up
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).
6-month follow-up
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
12-month follow-up
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
6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kensington Eye Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sherif El-Defrawy, MD, FRCSC, University of Toronto
  • Principal Investigator: Yaping Jin, MD, PhD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 108162330RR0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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