Synergy Lens Outcomes Evaluation

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05418153
• Other study ID #: CFS 21-001
• Status: Completed
• Start date: March 14, 2022
• Est. completion date: November 22, 2022

Study information

• Verified date: June 2022
• Source: Center For Sight
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia
• Pseudophakia

Intervention

Device:
• Tecnis Synergy IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

Locations

Country	Name	City	State
United States	Carolina Eyecare Physicians	Mount Pleasant	South Carolina
United States	Center For Sight	Venice	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Center For Sight	Science in Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions	Visual acuity measured at 40 cm	Up to 1 year
Primary	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