NCT03579368

Prospective Evaluation of the Tecnis Symfony Intraocular Lens (IOL)

Status unknown NA Last updated 6 July 2018

What this trial tests

NA trial testing Symfony implantation in Cataract in 200 participants. Status unknown.

Timeline

5 July 2018

Primary endpoint
15 April 2019

15 May 2019

Quick facts

Lead sponsor	Kovach Eye Institute
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	5 July 2018
Primary completion	15 April 2019
Estimated completion	15 May 2019

Drugs / interventions tested

• Symfony implantation

Conditions studied

• Cataract — all drugs for Cataract →
• Cataract Senile — all drugs for Cataract Senile →

Sponsor

Kovach Eye Institute

Who can join

18 and older, any sex, with Cataract or Cataract Senile. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.