Symfony/Synergy IOL Combination Outcomes

Presbyopia Clinical Trial

Official title:

Evaluating A Novel Strategy: The Synergy IOL Mixed and Matched With the Symfony With Intelilight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05604781
• Other study ID #: CFS-22-001
• Status: Completed
• Start date: October 17, 2022
• Est. completion date: May 16, 2023

Study information

• Verified date: August 2023
• Source: Center For Sight
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Subject is undergoing bilateral lens extraction with intraocular lens implantation of the Symfony with InteliLight in the dominant eye and a Synergy in the non-dominant eye.

2. Gender: Males and Females.

3. Age: 50 years and older.

4. Willing and able to provide written informed consent for participation in the study

5. Willing and able to comply with scheduled visits and other study procedures.

6. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 2 to 30 days between surgeries

7. Subjects who require an IOL power in the range of +5.00 D to +34.0 D only.

8. Subjects who require a toric IOL up to +3.75 D at the IOL plane (2.57 D corneal plane).

9. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

1. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.

2. Uncontrolled diabetes.

3. Use of any systemic or topical drug known to interfere with visual performance.

4. Contact lens use during the active treatment portion of the trial.

5. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.

6. Clinically significant corneal dystrophy

7. History of chronic intraocular inflammation.

8. History of retinal detachment.

9. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.

10. Previous intraocular surgery.

11. Previous corneal refractive surgery (i.e. LASIK, photorefractive keratectomy, radial keratotomy).

12. Previous keratoplasty

13. Severe dry eye

14. Pupil abnormalities

15. Anesthesia other than topical or peribulbar anesthesia (i.e. retrobulbar, general, etc).

16. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.

17. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Related Conditions & MeSH terms

• Bilateral Cataract
• Cataract
• Presbyopia

Intervention

Device:
• Symfony & Synergy IOL combination
The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.

Locations

Country	Name	City	State
United States	Helga Sandoval	Mount Pleasant	South Carolina
United States	Center For Sight	Venice	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Center For Sight	Science in Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular Defocus Curve		3 months
Secondary	Patient Satisfaction Questionnaire	Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed	3 months
Secondary	Spectacle Independence for Near Activities Questionnaire	Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed.	3 months