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

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: Terminated
• Conditions: Cataracts; Visual Acuity Reduced Transiently; Loss of Visual Contrast Sensitivity; Functional Visual Loss
• Intervention / Treatment: Device: Alcon 1 piece SA60AT lens; Device: AMO 1-piece AABOO lens

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: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 month follow-up
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.	18 month follow-up
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).	18 month follow-up
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	12-month follow-up
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.	12-month follow-up
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).	12-month follow-up
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.	6-month follow-up
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.	6-month follow-up
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).	6-month follow-up
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	12-month follow-up
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	6-month follow-up

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Kensington Eye Institute
• Investigators: Principal Investigator: Sherif El-Defrawy, MD, FRCSC, University of Toronto; Principal Investigator: Yaping Jin, MD, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cataract surgery; Intraocular lens; Glistenings
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID 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