Last updated: August 29, 2023
Sponsor: Center For Sight
Overall Status: Completed
Phase
N/A
Condition
Presbyopia
Treatment
Tecnis Synergy IOL
Clinical Study ID
NCT05418153
CFS 21-001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 segmentsurgeons at Center For Sight (DWS, WJL, JWK, WLS, and JOD) and 1 surgeon at CarolinaEyecare 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 inboth eyes.
Exclusion
Exclusion Criteria:
- Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis,and clinically-significant retinal pathology affecting the macula (with visual acuityworse than 20/32) and/or any other ocular findings that may, in the opinion of theinvestigator, 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 thatmay interfere with the interpretation of study results.
- Participation in (or current participation) any ophthalmic investigational drug orophthalmic device trial within the previous 30 days prior to the start date of thistrial.
- 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 rupturedzonules, torn capsule, or vitrectomy.
Study Design
Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Tecnis Synergy IOL
Phase:
Study Start date:
March 14, 2022
Estimated Completion Date:
November 22, 2022
Connect with a study center
Center For Sight
Venice, Florida 34285
United StatesSite Not Available
Carolina Eyecare Physicians
Mount Pleasant, South Carolina 29464
United StatesSite Not Available
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