NCT05604781

Symfony/Synergy IOL Combination Outcomes

Completed Results posted Last updated 18 March 2024

What this trial tests

trial testing Symfony & Synergy IOL combination in Bilateral Cataract in 41 participants. Completed in 16 May 2023.

Timeline

17 October 2022

Primary endpoint
16 May 2023

16 May 2023

Quick facts

Lead sponsor	Center For Sight
Status	Completed
Study type	OBSERVATIONAL
Enrollment	41
Start date	17 October 2022
Primary completion	16 May 2023
Estimated completion	16 May 2023
Sites	2 locations across United States

Drugs / interventions tested

• Symfony & Synergy IOL combination

Conditions studied

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

Sponsor

Center For Sight — full company profile →

Who can join

50 and older, any sex, with Bilateral Cataract 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 Defocus Curve Primary · 3 months

+1.00 D

Group	Value	95% CI
Symfony & Synergy IOL Combination	0.07	± 0.10

+0.50 D

Group	Value	95% CI
Symfony & Synergy IOL Combination	-0.05	± 0.08

0.00 D

Group	Value	95% CI
Symfony & Synergy IOL Combination	-0.08	± 0.12

-0.50 D

Group	Value	95% CI
Symfony & Synergy IOL Combination	-0.05	± 0.09

-1.00 D

Group	Value	95% CI
Symfony & Synergy IOL Combination	-0.04	± 0.10

-1.50 D

Group	Value	95% CI
Symfony & Synergy IOL Combination	-0.03	± 0.13

-2.00 D

Group	Value	95% CI
Symfony & Synergy IOL Combination	0.04	± 0.13

-2.50 D

Group	Value	95% CI
Symfony & Synergy IOL Combination	0.07	± 0.14

Patient Satisfaction Questionnaire Secondary · 3 months

Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed

Group	Value	95% CI
Symfony & Synergy IOL Combination	31

Spectacle Independence for Near Activities Questionnaire Secondary · 3 months

Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed.

Group	Value	95% CI
Symfony & Synergy IOL Combination	4

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 that evaluated 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 showed good outcomes with high patient satisfaction and less dependance on glasses for intermediate and near activities. As technology evolves, new lens models are available in the market. The purpose of this study is to evaluate the latest EDOF and a hybrid multifocal lenses when combined.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical performance after implantation of an EDOF intraocular lens in the dominant eye and a presbyopia-correcting intraocular lens in the nondominant eye.
   Soscia WL, DeRojas JO, Mathews PM, Brutsky A, et al · · 2024 · cited 6× · PMID 38305420 · DOI 10.1097/j.jcrs.0000000000001412