CompletedNot Applicable

Synergy Lens Outcomes Evaluation

United States52 participantsStarted 2022-03-14

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: Up to 1 year

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

Timeframe: Up to 1 year

Trial details

NCT IDNCT05418153

SponsorCenter For Sight

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-11-22

Results submitted2023-08-29

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