Clinical trial NCT05418153: Synergy Lens Outcomes Evaluation
Official title: Evaluating the New Synergy IOL - First 7 Months Data From Two US Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Pseudophakia
Lead sponsor: Center For Sight
Sponsor class: OTHER
Collaborators: name: Science in Vision
First posted: 2022-06-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent routine, uneventful cataract surgery with implantation of the Synergy lens in both eyes between 01June2021 and 31Dec2021 at Center For Sight (Sarasota, FL) and Carolina Eyecare Physicians (Charleston, SC)

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


Eligibility criteria: Inclusion Criteria:

1. Age: 18 years and older.
2. Gender: Males and Females.
3. Uneventful bilateral lens extraction
4. 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.
5. Willing and able to provide written informed consent for participation in the study.
6. Willing and able to comply with scheduled visit and study examination procedures.
7. At least 3 months postoperative from second eye IOL implantation.
8. Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

1. 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.
2. Uncontrolled diabetes.
3. Use of any systemic or topical drug known to interfere with visual performance.
4. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
5. Clinically significant corneal dystrophy.
6. Irregular astigmatism.
7. History of chronic intraocular inflammation.
8. Previous intraocular surgery.
9. Previous keratoplasty
10. Previous refractive surgery.
11. Severe dry eye
12. Pupil abnormalities
13. Any clinically significant, serious or severe medical or psychiatric condition that may interfere with the interpretation of study results.
14. 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.
15. Best-corrected distance visual acuity worse than 20/32 in each eye.
16. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
17. Abnormal iris
18. Patients who had a complication during cataract surgery, which could include ruptured zonules, torn capsule, or vitrectomy.

Primary outcomes:
measure: Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions
timeFrame: Up to 1 year
measure: Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Venice
country: United States
facility: Center For Sight
state: Florida
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians
state: South Carolina
Study officials:
References: