Synergy Lens Outcomes Evaluation

Study Overview
=================
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

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

Conditions
-----------------
Presbyopia, Pseudophakia

Intervention / Treatment
-----------------
* Device: Tecnis Synergy IOL


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Synergy IOL<br>Patients implanted with the Synergy IOL in both eyes. | Device: Tecnis Synergy IOL<br>* Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Participants will answer a questionnaire to determine the satisfaction with near activities. Possible answers include Completely, mostly, moderately, a little and not all satisfied. | Up to 1 year |