Synergy Lens Outcomes Evaluation
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Synergy IOL Patients implanted with the Synergy IOL in both eyes. |
Device: Tecnis Synergy IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
|
Outcome Measures
Primary Outcome Measures
- Binocular distance corrected near visual acuity at 40 cm under photopic conditions [Up to 1 year]
Visual acuity measured at 40 cm
- Binocular distance corrected near visual acuity at 40 cm under mesopic conditions [Up to 1 year]
Visual acuity measured at 40 cm under dim light
Secondary Outcome Measures
- Patient satisfaction [Up to 1 year]
Participants will answer a questionnaire to determine the satisfaction with near activities. Possible answers include Completely, mostly, moderately, a little and not all satisfied.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 18 years and older.
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Gender: Males and Females.
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Uneventful bilateral lens extraction
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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.
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Willing and able to provide written informed consent for participation in the study.
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Willing and able to comply with scheduled visit and study examination procedures.
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At least 3 months postoperative from second eye IOL implantation.
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Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion Criteria:
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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.
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Uncontrolled diabetes.
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Use of any systemic or topical drug known to interfere with visual performance.
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Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
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Clinically significant corneal dystrophy.
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Irregular astigmatism.
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History of chronic intraocular inflammation.
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Previous intraocular surgery.
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Previous keratoplasty
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Previous refractive surgery.
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Severe dry eye
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Pupil abnormalities
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Any clinically significant, serious or severe medical or psychiatric condition that may interfere with the interpretation of study results.
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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.
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Best-corrected distance visual acuity worse than 20/32 in each eye.
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Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
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Abnormal iris
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Patients who had a complication during cataract surgery, which could include ruptured zonules, torn capsule, or vitrectomy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center For Sight | Venice | Florida | United States | 34285 |
| 2 | Carolina Eyecare Physicians | Mount Pleasant | South Carolina | United States | 29464 |
Sponsors and Collaborators
- Center For Sight
- Science in Vision
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CFS 21-001