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Completed

NCT Number: NCT05418153

Synergy Lens Outcomes Evaluation

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

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Key information

Conditions

Presbyopia Eye Diseases Pathological Conditions, Signs and Symptoms Pseudophakia Refractive Errors Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center For Sight, Venice, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

Tecnis Synergy IOL

Device

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

Primary outcomes

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

    Time frame: Up to 1 year

    Visual acuity measured at 40 cm

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

    Time frame: Up to 1 year

    Visual acuity measured at 40 cm under dim light

Sponsors and collaborators

Lead sponsor

Center For Sight

Other

Collaborators

  • Science in Vision

Registry information

Official study title

Evaluating the New Synergy IOL - First 7 Months Data From Two US Centers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2022
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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