Prospective Evaluation of the Tecnis Symfony Intraocular Lens (IOL)

NCT03579368 | Unknown

• 1 other identifier: Pro00025285
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Advances in cataract surgery and premium IOLs have allowed the ophthalmologist and optometrist to embrace the fact, as with Lasik patients, that refractive cataract surgery can allow their patients to be potentially free or less dependent on glasses. However, fewer than 13% of all patients undergoing cataract surgery today choose a premium IOL and of these approximately 5% are presbyopic IOLs. The need for greater optometric involvement in cataract surgery is necessary as demand for cataract surgery increases with the population ageing. According to a recent American Optometric Association survey, optometrists diagnose, on average, 13 cases of cataracts per month and refer or co-manage about half of them that are sent for surgery. Since patients base their decision and selection primarily on doctor recommendations, it is incumbent on the optometric community to be well informed on the benefits of the Advanced Technology IOLs. There is currently no data that has been collected comparing Advanced Technology IOLs and their clinical outcome and acceptance rate among patients co-managed with optometrists. This pilot study will study the subjective visual symptoms, spectacle independence at various distances and patient satisfaction after bilateral implantation of the Tecnis Symfony Extended Range of Vision Advanced Technology IOL in this co-managed care environment. The primary assessment tool will be a Non-directed Patient Satisfaction and Symptoms Questionnaire. Initial questions would include; "How satisfied are you with your spectacle-free vision at distance/intermediate/near?", "Would you choose the same lens again?" and "Would you recommend the same lens to your relatives and friends". Similarly, with regard to Photic phenomena / visual symptoms, we would ask "Do you experience any problems with your vision?" and only follow up with specific questions on severity once the patient volunteers a specific symptom.. The surgery form will include a question determining the surgeon's satisfaction with the individual Symfony lens implantation. At last visit the optometric investigator will be asked about his satisfaction with the performance of the Symfony lens. This will allow monitoring of any progression of satisfaction as more experience with the lens is obtained.

Conditions

Cataract; Cataract Senile

Keywords

Cataract; IOL; Presbyopia Correcting IOL; Patient Satisfaction; Spectacle Independence

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction & Spectacle independence

  Patient questionaire

  3 months postoperatively

Secondary Outcomes (7)

• Patient satisfaction & Spectacle independence

  1 month postoperatively

• Surgeon Satisfaction

  Intraoperative

• Referring Optometrist Satisfaction

  3 months postoperatively

• Patient Symptoms

  1 month postoperative

• Patient Symptoms

  3 months postoperative

Study Arms (1)

Symfony Implantation

OTHER

Patients undergoing bilateral IOL implantation with the Tecnis Symfony Extended Range of Vision IOL at a single surgical site

Device: Symfony implantation

Interventions

Symfony implantation DEVICE

Bilateral Symfony IOL Implantation

Symfony Implantation

Eligibility Criteria

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

You may qualify if:

• Patients bilaterally implanted with the Tecnis® Symfony Extended Range of Vision IOL
• Age 18 and older
• Patient targeted for emmetropic refraction both eyes (OU)
• Postoperative refractive spherical equivalent within ± 0.5 Diopters OU
• Postoperative refractive cylinder of ≤ 0.75 Diopters OU
• Clear intraocular media
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Subjects must have best corrected visual acuity (BCDVA) better than 20/30 after cataract removal and IOL implantation OU

You may not qualify if:

• Acute or chronic diseases or illness that would increase risk or confound study results, such as proliferative or moderate to severe background diabetic retinopathy, macular degeneration, or cystoid macular edema.
• Subjects with any anterior pathology that would be likely to increase the risk of complications from cataract and IOL surgery such as keratoconus, Fuchs dystrophy or any other previous serious corneal disease, pupil irregularity, unmanaged (severe) dry eyes, ocular infection or inflammation or uncontrolled glaucoma.
• Subjects with associated ocular conditions that could affect the stability of the IOL such as zonular dialysis or pseudoexfoliation syndrome.
• Subjects with central nervous system or motility issue such as dementia or alternating mono-fixators, e.g. amblyopia or strabismus
• Subjects with intra-operative complications such as posterior capsule rupture, or other unresolved complications affecting visual outcome
• History of any refractive or intraocular surgery (not including treatment for retinal holes)
• Clinically significant Ptosis
• Pupil abnormalities (non-reactive, tonic, abnormally shaped pupils, or pupils that do not dilate at least 3.5mm under mesopic/scotopic conditions)
• Use of systemic or ocular medication that might affect vision
• Patients whose primary visual requirement postoperatively is crisp, clear uncorrected visual acuity for near distances at less than 20 inches.
• Active ocular surface disease affecting the refractive surface properties of the cornea (i.e. Meibomian gland dysfunction, or moderate to severe dry eye etc.)

Sponsors & Collaborators

• Kovach Eye Institute: lead

MeSH Terms

Conditions

Cataract; Patient Satisfaction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Donald R Sanders

  Center for Clinical Research

  STUDY DIRECTOR

Central Study Contacts

Donald R Sanders, MD. PhD

CONTACT

630-530-9700; drsmd@drsmd.com

Wes Becton

CONTACT

630-833-9621; wes@kovacheye.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group study

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 6, 2018
• Study Start: July 5, 2018
• Primary Completion: April 15, 2019
• Study Completion: May 15, 2019
• Last Updated: July 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share