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CataractsNCT03409185

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

A study testing Alcon 1 piece SA60AT lens and AMO 1-piece AABOO lens in people with Cataracts and Visual Acuity Reduced Transiently, run by University of Toronto at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alcon 1 piece SA60AT lens and AMO 1-piece AABOO lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
11 Jul 2017to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Kensington Eye Institute

    Toronto, Ontario, M5T3A9

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Alcon 1 piece SA60AT lens, AMO 1-piece AABOO lens
Keywords
Cataract surgery, Intraocular lens, Glistenings
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alcon 1 piece SA60AT lensDevice

    Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-absorbing Acrylate/Methacrylate Copolymer

  • AMO 1-piece AABOO lensDevice

    Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-blocking hydrophobic acrylic

Study groups in NCT03409185
Study groupRoleWhat they receive
Alcon lens groupExperimentalAlcon 1 piece SA60AT lens
Receives: Device: Alcon 1 piece SA60AT lens
AMO lens groupActive comparatorAMO 1 piece Sensar AABOO lens
Receives: Device: AMO 1-piece AABOO lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and density (severity) of glistenings at 18-month follow-up visit

    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:

    1. No glistening
    2. Less than 10 glistenings
    3. 10 to 25 glistenings
    4. 25 to 50 glistenings
    5. 50 to 100 glistenings
    6. Greater than 100 glistenings

    Measured: 18-month follow-up

Secondary outcomes (11)

  1. Visual acuity in eyes with glistenings at 18-month follow-up visit

    Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart.

    Measured: 18 month follow-up

  2. Contrast sensitivity in eyes with glistenings at 18-month follow-up visit

    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.

    Measured: 18 month follow-up

  3. Glare disability in eyes with glistenings at 18-month follow-up visit

    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).

    Measured: 18 month follow-up

  4. Visual acuity in eyes with glistenings at 12-month follow-up visit

    Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart

    Measured: 12-month follow-up

  5. Contrast sensitivity and glare disability in eyes with glistenings at 12-month follow-up visit

    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.

    Measured: 12-month follow-up

  6. Glare disability in eyes with glistenings at 12-month follow-up visit

    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).

    Measured: 12-month follow-up

  7. Visual acuity in eyes with glistenings at 6-month follow-up visit

    Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart.

    Measured: 6-month follow-up

  8. Contrast sensitivity in eyes with glistenings at 6-month follow-up visit

    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.

    Measured: 6-month follow-up

  9. Glare disability in eyes with glistenings at 6-month follow-up visit

    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).

    Measured: 6-month follow-up

  10. Incidence of glistenings at 12-month follow-up visit

    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:

    1. No glistening
    2. Less than 10 glistenings
    3. 10 to 25 glistenings
    4. 25 to 50 glistenings
    5. 50 to 100 glistenings
    6. Greater than 100 glistenings

    Measured: 12-month follow-up

  11. Incidence of glistenings at 6-month follow-up visit

    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:

    1. No glistening
    2. Less than 10 glistenings
    3. 10 to 25 glistenings
    4. 25 to 50 glistenings
    5. 50 to 100 glistenings
    6. Greater than 100 glistenings

    Measured: 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2018
  2. Study start11 Jul 2017
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Why it stopped: The study was terminated because of low recruitment/enrolment due to multiple reasons, including 1) Elderly population, often with other health issues, thus not being able to commit to all of the follow-up appointments and 2) COVID-19 restrictions.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03409185
Sponsor's protocol ID
108162330RR0001
Status last verified
Dec 2023
First submitted
18 Dec 2017
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Alcon 1 piece SA60AT lens and AMO 1-piece AABOO lens in people with Cataracts and Visual Acuity Reduced Transiently, run by University of Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was terminated because of low recruitment/enrolment due to multiple reasons, including 1) Elderly population, often with other health issues, thus not being able to commit to all of the follow-up appointments and 2) COVID-19 restrictions.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and density (severity) of glistenings at 18-month follow-up visit (time frame: 18-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03409185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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