The Incidence of Glistenings in the 2017 Intraocular Lenses Made by Alcon and Abbott Medical Optics
NCT ID: NCT03409185
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
22 participants
INTERVENTIONAL
2017-07-11
2023-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Alcon lens group
Alcon 1 piece SA60AT lens
Alcon 1 piece SA60AT lens
Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-absorbing Acrylate/Methacrylate Copolymer
AMO lens group
AMO 1 piece Sensar AABOO lens
AMO 1-piece AABOO lens
Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-blocking hydrophobic acrylic
Interventions
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Alcon 1 piece SA60AT lens
Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-absorbing Acrylate/Methacrylate Copolymer
AMO 1-piece AABOO lens
Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-blocking hydrophobic acrylic
Eligibility Criteria
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Inclusion Criteria
* Patients aged 18 years or older
* Patients who signed the consent form
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Kensington Eye Institute
OTHER
University of Toronto
OTHER
Responsible Party
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Yaping Jin
Associate Professor in Ophthalmic Epidemiology
Principal Investigators
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Sherif El-Defrawy, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Yaping Jin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Kensington Eye Institute
Toronto, Ontario, Canada
Countries
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Other Identifiers
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108162330RR0001
Identifier Type: -
Identifier Source: org_study_id