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

University of Toronto

Status

Terminated

Conditions

Functional Visual Loss

Loss of Visual Contrast Sensitivity

Cataracts

Visual Acuity Reduced Transiently

Treatments

Device: Alcon 1 piece SA60AT lens

Device: AMO 1-piece AABOO lens

Study type

Interventional

Funder types

Other

Identifiers

NCT03409185

108162330RR0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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