NCT03771274

Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

Completed NA Results posted Last updated 10 August 2020

What this trial tests

NA trial testing Tecnis ZLB00 & Symfony IOL in Cataract Bilateral in 39 participants. Completed in 31 October 2019.

Timeline

7 December 2018

Primary endpoint
31 October 2019

31 October 2019

Quick facts

Lead sponsor	Carolina Eyecare Physicians, LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	7 December 2018
Primary completion	31 October 2019
Estimated completion	31 October 2019
Sites	1 location across United States

Drugs / interventions tested

• Tecnis ZLB00 & Symfony IOL

Conditions studied

• Cataract Bilateral — all drugs for Cataract Bilateral →
• Presbyopia — all drugs for Presbyopia →

Sponsor

Carolina Eyecare Physicians, LLC — full company profile →

Who can join

40 and older, any sex, with Cataract Bilateral or Presbyopia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Binocular Uncorrected Near (40 cm) Visual Acuity. Primary · 3 months

Visual acuity measured at 40 cm without wearing any correction.

Group	Value	95% CI
Tecnis ZLB00 & Symfony IOL	0.13	± 0.09

Patient Visual Satisfaction After Cataract Surgery: Questionnaire Secondary · 3 months

Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: "Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision". Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied.

Group	Value	95% CI
Tecnis ZLB00 & Symfony IOL	27
Tecnis ZLB00 & Symfony IOL	5
Tecnis ZLB00 & Symfony IOL	7

Spectacle Independence: Questionnaire Secondary · 3 months

Patient's spectacle independence was assessed using the "Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No.

Yes

Group	Value	95% CI
Tecnis ZLB00 & Symfony IOL	12

No

Group	Value	95% CI
Tecnis ZLB00 & Symfony IOL	27

Number of Participants With Visual Symptoms Secondary · 3 months

Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.

Halos : Yes

Group	Value	95% CI
Tecnis ZLB00 & Symfony IOL	25

Halos : No

Group	Value	95% CI
Tecnis ZLB00 & Symfony IOL	14

Sensitivity to light: Yes

Group	Value	95% CI
Tecnis ZLB00 & Symfony IOL	23

Sensitivity to light: No

Group	Value	95% CI
Tecnis ZLB00 & Symfony IOL	16

Sponsor's own description

Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes were targeted for plano and when the non-dominant eye was set for a small residual myopic error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared to provide similar binocular acuity at distance and intermediate but better acuity at near. The purpose of this study is to evaluate the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.