Last updated: August 31, 2023
Sponsor: Center For Sight
Overall Status: Completed
Phase
N/A
Condition
Eye Disorders/infections
Vision Loss
Presbyopia
Treatment
Symfony & Synergy IOL combination
Clinical Study ID
NCT05604781
CFS-22-001
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject is undergoing bilateral lens extraction with intraocular lens implantation ofthe Symfony with InteliLight in the dominant eye and a Synergy in the non-dominanteye.
- Gender: Males and Females.
- Age: 50 years and older.
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyeswithin 2 to 30 days between surgeries
- Subjects who require an IOL power in the range of +5.00 D to +34.0 D only.
- Subjects who require a toric IOL up to +3.75 D at the IOL plane (2.57 D cornealplane).
- Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in botheyes.
Exclusion
Exclusion Criteria:
- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferativediabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment,aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization,medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerveatrophy, macular degeneration (with anticipated best postoperative visual acuity lessthan 20/30), advanced glaucomatous damage, etc.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- Clinically significant corneal dystrophy
- History of chronic intraocular inflammation.
- History of retinal detachment.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken thezonules.
- Previous intraocular surgery.
- Previous corneal refractive surgery (i.e. LASIK, photorefractive keratectomy, radialkeratotomy).
- Previous keratoplasty
- Severe dry eye
- Pupil abnormalities
- Anesthesia other than topical or peribulbar anesthesia (i.e. retrobulbar, general,etc).
- Any clinically significant, serious or severe medical or psychiatric condition thatmay increase the risk associated with study participation or may interfere with theinterpretation 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.
Study Design
Total Participants: 41
Treatment Group(s): 1
Primary Treatment: Symfony & Synergy IOL combination
Phase:
Study Start date:
October 17, 2022
Estimated Completion Date:
May 16, 2023
Connect with a study center
Center For Sight
Venice, Florida 34285
United StatesSite Not Available
Helga Sandoval
Mount Pleasant, South Carolina 29464
United StatesSite Not Available

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