The Incidence of Glistenings in the 2017 Intraocular Lenses Made by Alcon and Abbott Medical Optics
Primary Purpose
Cataracts, Visual Acuity Reduced Transiently, Loss of Visual Contrast Sensitivity
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Alcon 1 piece SA60AT lens
AMO 1-piece AABOO lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts focused on measuring Cataract surgery, Intraocular lens, Glistenings
Eligibility 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
Sites / Locations
- Kensington Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alcon lens group
AMO lens group
Arm Description
Alcon 1 piece SA60AT lens
AMO 1 piece Sensar AABOO lens
Outcomes
Primary Outcome Measures
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:
0. No glistening
Less than 10 glistenings
10 to 25 glistenings
25 to 50 glistenings
50 to 100 glistenings
Greater than 100 glistenings
Secondary Outcome Measures
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.
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.
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).
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
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.
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).
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.
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.
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).
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:
0. No glistening
Less than 10 glistenings
10 to 25 glistenings
25 to 50 glistenings
50 to 100 glistenings
Greater than 100 glistenings
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:
0. No glistening
Less than 10 glistenings
10 to 25 glistenings
25 to 50 glistenings
50 to 100 glistenings
Greater than 100 glistenings
Full Information
NCT ID
NCT03409185
First Posted
December 18, 2017
Last Updated
May 16, 2022
Sponsor
University of Toronto
Collaborators
Kensington Eye Institute
1. Study Identification
Unique Protocol Identification Number
NCT03409185
Brief Title
The Incidence of Glistenings in the 2017 Intraocular Lenses Made by Alcon and Abbott Medical Optics
Official Title
The Incidence of Glistenings in the 2017 Generation of Hydrophobic Acrylic Lenses Manufactured by Alcon and Abbott Medical Optics
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Kensington Eye Institute
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts, Visual Acuity Reduced Transiently, Loss of Visual Contrast Sensitivity, Functional Visual Loss
Keywords
Cataract surgery, Intraocular lens, Glistenings
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alcon lens group
Arm Type
Experimental
Arm Description
Alcon 1 piece SA60AT lens
Arm Title
AMO lens group
Arm Type
Active Comparator
Arm Description
AMO 1 piece Sensar AABOO lens
Intervention Type
Device
Intervention Name(s)
Alcon 1 piece SA60AT lens
Intervention Description
Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-absorbing Acrylate/Methacrylate Copolymer
Intervention Type
Device
Intervention Name(s)
AMO 1-piece AABOO lens
Intervention Description
Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-blocking hydrophobic acrylic
Primary Outcome Measure Information:
Title
Incidence and density (severity) of glistenings at 18-month follow-up visit
Description
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
Less than 10 glistenings
10 to 25 glistenings
25 to 50 glistenings
50 to 100 glistenings
Greater than 100 glistenings
Time Frame
18-month follow-up
Secondary Outcome Measure Information:
Title
Visual acuity in eyes with glistenings at 18-month follow-up visit
Description
Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart.
Time Frame
18 month follow-up
Title
Contrast sensitivity in eyes with glistenings at 18-month follow-up visit
Description
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.
Time Frame
18 month follow-up
Title
Glare disability in eyes with glistenings at 18-month follow-up visit
Description
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).
Time Frame
18 month follow-up
Title
Visual acuity in eyes with glistenings at 12-month follow-up visit
Description
Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart
Time Frame
12-month follow-up
Title
Contrast sensitivity and glare disability in eyes with glistenings at 12-month follow-up visit
Description
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.
Time Frame
12-month follow-up
Title
Glare disability in eyes with glistenings at 12-month follow-up visit
Description
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).
Time Frame
12-month follow-up
Title
Visual acuity in eyes with glistenings at 6-month follow-up visit
Description
Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart.
Time Frame
6-month follow-up
Title
Contrast sensitivity in eyes with glistenings at 6-month follow-up visit
Description
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.
Time Frame
6-month follow-up
Title
Glare disability in eyes with glistenings at 6-month follow-up visit
Description
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).
Time Frame
6-month follow-up
Title
Incidence of glistenings at 12-month follow-up visit
Description
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
Less than 10 glistenings
10 to 25 glistenings
25 to 50 glistenings
50 to 100 glistenings
Greater than 100 glistenings
Time Frame
12-month follow-up
Title
Incidence of glistenings at 6-month follow-up visit
Description
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
Less than 10 glistenings
10 to 25 glistenings
25 to 50 glistenings
50 to 100 glistenings
Greater than 100 glistenings
Time Frame
6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif El-Defrawy, MD, FRCSC
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yaping Jin, MD, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kensington Eye Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T3A9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Incidence of Glistenings in the 2017 Intraocular Lenses Made by Alcon and Abbott Medical Optics
We'll reach out to this number within 24 hrs