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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05604781
Other study ID # CFS-22-001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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