Synergy Lens Outcomes Evaluation

Completed

• Conditions: Presbyopia; Pseudophakia
• Interventions: Device: Tecnis Synergy IOL

• Registration Number: NCT05418153
• Lead Sponsor: Center For Sight

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-14
• Status Verified: 2022-06
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-14
• Primary Completion: 2022-11-22
• Study Completion: 2022-11-22
• Results First Submitted: 2023-08-29
• Results First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Results First Posted: 2024-03-18
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Synergy IOL	Tecnis Synergy IOL	Patients implanted with the Synergy IOL in both eyes.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Carolina Eyecare Physicians; 🇺🇸 Mount Pleasant, South Carolina, United States

Center For Sight; 🇺🇸 Venice, Florida, United States