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

Sponsor
University of Toronto (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03409185
Collaborator
Kensington Eye Institute (Other)
200
Enrollment
1
Location
2
Arms
52.7
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Alcon 1 piece SA60AT lens
  • Device: AMO 1-piece AABOO lens
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Incidence of Glistenings in the 2017 Generation of Hydrophobic Acrylic Lenses Manufactured by Alcon and Abbott Medical Optics
Actual Study Start Date :
Jul 11, 2017
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

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

    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

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

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

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

    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.

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

    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).

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

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

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

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

    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).

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

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

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

    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.

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

    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).

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

    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

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

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Kensington Eye InstituteTorontoOntarioCanadaM5T3A9

Sponsors and Collaborators

  • University of Toronto
  • Kensington Eye Institute

Investigators

  • Principal Investigator: Sherif El-Defrawy, MD, FRCSC, University of Toronto
  • Principal Investigator: Yaping Jin, MD, PhD, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yaping Jin, Associate Professor in Ophthalmic Epidemiology, University of Toronto
ClinicalTrials.gov Identifier:
NCT03409185
Other Study ID Numbers:
  • 108162330RR0001
First Posted:
Jan 24, 2018
Last Update Posted:
Nov 3, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by Yaping Jin, Associate Professor in Ophthalmic Epidemiology, University of Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2020