Visual Field Changes in TECNIS ZCB00 Monofocal vs. TECNIS Symfony Extended Depth of Focus Intraocular Lens Implantation

NCT03505827 | Withdrawn FDA Device

• 1 other identifier: 111201
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Glaucoma is a leading cause of blindness worldwide. Damage to the optic nerve results in vision loss gradually. This vision loss can be detected by using visual field testing, and is a way of monitoring glaucoma progression. As this population ages, cataracts develop, and patients need to undergo cataract surgery to replace the cloudy crystalline lens with an artificial intraocular lens (IOL). The standard of treatment is implantation of a monofocal IOL, but this limits depth of focus and does not allow clear vision at both distance and near without glasses post-operatively. Multifocal and trifocal lenses split light into multiple distinct foci at near, intermediate and far distances without glasses correction. However, these lenses have been shown to reduce contrast sensitivity and impair visual field testing results, and are not recommended in patients with glaucoma. The TECNIS Symfony IOL has recently been approved by Health Canada and offers an extended range of vision with a single elongated focal point to allow patients to see at both distance and near. The lens is advertised to enhance contrast sensitivity, but it is currently unknown whether the TECNIS Symfony IOL impacts visual field testing. We will study the visual field changes in patients undergoing both TECNIS ZCB00 monofocal and TECNIS Symfony extended depth of focus IOL implantation during cataract surgery. The results of this study will impact the advice cataract surgeons give to patients with glaucoma, regarding whether this population of patients would benefit from a standard monofocal IOL implantation or an extended depth of focus TECNIS Symfony IOL implantation.

Conditions

Lenses, Intraocular; Visual Fields; Cataract

Keywords

TECNIS Symfony

Outcome Measures

Primary Outcomes (1)

• Mean Deviation

  An overall value of the total amount of visual field loss

  1 year

Secondary Outcomes (1)

• Pattern Standard Deviation

  1 year

Study Arms (2)

TECNIS Monofocal

This group of patients has chosen to undergo implantation of a TECNIS monofocal ZCB00 lens during cataract surgery. This decision was made prior to enrolment in the study. This group of patients will receive standard of care cataract surgery, as any other patient would. The sole intervention we will be undertaking is a 24-2 Humphrey visual field test prior to surgery, and a 24-2 SITA standard Humphrey visual field test after surgery at 1 month post-operatively.

Diagnostic Test: 24-2 SITA Standard Humphrey Visual Field Test

TECNIS Symfony

This group of patients has chosen to undergo implantation of a TECNIS Symfony extended depth of focus lens during cataract surgery. This decision was made prior to enrolment in the study. This group of patients will receive standard of care cataract surgery, as any other patient would. The sole intervention we will be undertaking is a 24-2 SITA standard Humphrey visual field test prior to surgery, and a 24-2 Humphrey visual field test after surgery at 1 month post-operatively.

Diagnostic Test: 24-2 SITA Standard Humphrey Visual Field Test

Interventions

24-2 SITA Standard Humphrey Visual Field Test DIAGNOSTIC_TEST

Patients participate in a 24-2 SITA Standard humphrey visual field test. This includes sitting in a dark room at a visual field machine. Stimulus test points of different intensity and size will be presented to the patient, as per SITA standard protocol. The patient will indicate by pressing a button when they see the visual stimulus.

TECNIS Monofocal; TECNIS Symfony

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any adult patients undergoing cataract surgery at the Ivey Eye Clinic in London, Ontario, Canda who chose to receive a TECNIS Symfony intraocular lens implant or TECNIS monofocal ZCB00 intraocular lens implant will be approached to be enrolled in the study AFTER determining their decision to undergo cataract surgery and decision of lens implantation has been made.

You may qualify if:

• Patients who have chosen to undergo elective cataract surgery in one eye with 20/40 - 20/100 vision (best corrected) in the operated eye on initial pre-op surgical assessment and with greater than or equal to 20/25 vision (best corrected) in the operated eye at 1-month post-operatively.
• Patients who have chosen to undergo TECNIS ZCB00 monofocal intraocular lens implantation.
• Patients who have chosen to undergo implantation of a TECNIS Symfony extended depth of focus intraocular lens.
• Patient must be able to reliably perform visual field testing.
• No other eye disease other than cataract.
• Patient must be older than 18 years of age.
• Patient must be proficient in the English language.

You may not qualify if:

• Patients who are unwilling or unable to undergo visual field testing.
• Patients with glaucoma.
• Patients who have history of laser refractive surgery.
• Patients who experienced an intra-operative complication.

Sponsors & Collaborators

• Western University, Canada: lead
• Ivey Eye Institute: collaborator

Study Sites (2)

Ivey Eye Institute

London, Ontario, N6A 4V2, Canada

Location

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

Related Publications (5)

• Farid M, Chak G, Garg S, Steinert RF. Reduction in mean deviation values in automated perimetry in eyes with multifocal compared to monofocal intraocular lens implants. Am J Ophthalmol. 2014 Aug;158(2):227-231.e1. doi: 10.1016/j.ajo.2014.04.017. Epub 2014 Apr 29.

  PMID: 24784872 BACKGROUND

• de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.

  PMID: 29138533 BACKGROUND

• Shen Z, Lin Y, Zhu Y, Liu X, Yan J, Yao K. Clinical comparison of patient outcomes following implantation of trifocal or bifocal intraocular lenses: a systematic review and meta-analysis. Sci Rep. 2017 Mar 28;7:45337. doi: 10.1038/srep45337.

  PMID: 28422087 BACKGROUND

• Nouri-Mahdavi K. Selecting visual field tests and assessing visual field deterioration in glaucoma. Can J Ophthalmol. 2014 Dec;49(6):497-505. doi: 10.1016/j.jcjo.2014.10.002.

  PMID: 25433738 BACKGROUND

• Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.

  PMID: 24974815 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Tony Lin, MD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 23, 2018
• Study Start: June 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)