Synergy Lens Outcomes Evaluation

NCT05418153 | Completed Results FDA Device

• 1 other identifier: CFS 21-001
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Presbyopia; Pseudophakia

Outcome Measures

Primary Outcomes (2)

• Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions

  Visual acuity measured at 40 cm

  Up to 1 year

• Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions

  Visual acuity measured at 40 cm under dim light

  Up to 1 year

Study Arms (1)

Synergy IOL

Patients implanted with the Synergy IOL in both eyes.

Device: Tecnis Synergy IOL

Interventions

Tecnis Synergy IOL DEVICE

Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

Synergy IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent routine, uneventful cataract surgery with implantation of the Synergy lens in both eyes between 01June2021 and 31Dec2021 at Center For Sight (Sarasota, FL) and Carolina Eyecare Physicians (Charleston, SC)

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.

Sponsors & Collaborators

• Center For Sight: lead
• Science in Vision: collaborator

Study Sites (2)

Center For Sight

Venice, Florida, 34285, United States

Location

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Presbyopia; Pseudophakia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Center For Sight

hsandoval@cepmd.com

8438813937

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 14, 2022
• Study Start: March 14, 2022
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2022-06

Locations

US (2)