Synergy Lens Outcomes Evaluation

Completed

Conditions studied: Presbyopia, Pseudophakia

In brief

This is a single visit study to evaluate the visual outcomes and patient satisfaction of patients who were bilaterally implanted with the Tecnis Synergy IOL between June 1 and December 31, 2021 in 2 centers in USA

Key facts

Study ID

NCT05418153

Run by

Center For Sight

People needed

52

Starts

2022-03-14

Expected to finish

2022-11-22

Last updated by the study team

2024-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18 years and older.
• Gender: Males and Females.
• Uneventful bilateral lens extraction
• Bilateral implantation of Synergy IOLs (toric and non-toric) by 5 anterior segment surgeons at Center For Sight (DWS, WJL, JWK, WLS, and JOD) and 1 surgeon at Carolina Eyecare Physicians (KDS) through the months of June to December 2021.
• Willing and able to provide written informed consent for participation in the study.
• Willing and able to comply with scheduled visit and study examination procedures.
• At least 3 months postoperative from second eye IOL implantation.
• Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

You may not qualify if…

• Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/32) and/or any other ocular findings that may, in the opinion of the investigator, affect vision.
• Uncontrolled diabetes.
• Use of any systemic or topical drug known to interfere with visual performance.
• Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
• Clinically significant corneal dystrophy.
• Irregular astigmatism.
• History of chronic intraocular inflammation.
• Previous intraocular surgery.
• Previous keratoplasty
• Previous refractive surgery.
• Severe dry eye
• Pupil abnormalities
• Any clinically significant, serious or severe medical or psychiatric condition that may interfere with the interpretation of study results.
• 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.
• Best-corrected distance visual acuity worse than 20/32 in each eye.
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• Abnormal iris
• Patients who had a complication during cataract surgery, which could include ruptured zonules, torn capsule, or vitrectomy.

Where it is running

• Center For Sight — Venice, Florida, United States
• Carolina Eyecare Physicians — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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