N/A
Completed N=52
Synergy Lens Outcomes Evaluation
Presbyopia · Pseudophakia
Source: ClinicalTrials.gov NCT05418153 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions — 0.01 logMAR
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions |
0.01 | — |
| PRIMARY Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions |
0.21 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05418153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.