Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
64 participants
INTERVENTIONAL
2023-12-01
2024-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Symfony IOL
The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Symfony IOL
The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Vivity IOL
The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Vivity IOL
The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Interventions
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Symfony IOL
The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Vivity IOL
The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Eligibility Criteria
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Inclusion Criteria
2. Gender: Males and Females.
3. Age: 50 years and older.
4. Willing and able to provide written informed consent for participation in the study
5. Willing and able to comply with scheduled visits and other study procedures.
6. Scheduled to undergo standard cataract surgery in both eyes, with 1 to 30 days between surgeries.
7. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion Criteria
2. Uncontrolled diabetes.
3. Use of any systemic or topical drug known to interfere with visual performance.
4. Contact lens use during the active treatment portion of the trial.
5. Any concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis.
6. Clinically significant corneal dystrophy.
7. Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities.
8. History of chronic intraocular inflammation.
9. History of retinal detachment.
10. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
11. Previous intraocular surgery.
12. Previous corneal refractive surgery (i.e., LASIK, PRK, RK).
13. Subject who declined any type of presbyopia correcting IOL due to concerns with visual disturbances (i.e., halos)
14. Previous keratoplasty
15. Severe dry eye
16. Pupil abnormalities
17. Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK)
18. Any clinically significant, serious, or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
19. 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.
50 Years
ALL
No
Sponsors
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Science in Vision
OTHER
Carolina Eyecare Physicians, LLC
OTHER
Responsible Party
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Locations
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Center for Sight
Sarasota, Florida, United States
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CEP 23-001
Identifier Type: -
Identifier Source: org_study_id
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