Monofocal IOL Visual Outcomes When Targeting Mini Monovision
NCT ID: NCT05069415
Last Updated: 2024-02-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2021-10-04
2022-11-30
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
SINGLE
Study Groups
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Emmetropia
The target refraction for both eyes will be emmetropia (± 0.25 D).
Eyhance IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.
Eyhance IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.
Mini monovision
The target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15.
Eyhance IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.
Eyhance IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.
Interventions
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Eyhance IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.
Eyhance IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.
Eligibility Criteria
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Inclusion Criteria
* 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 in both eyes within 6 - 30 days between surgeries.
* Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
* Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion Criteria
* 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.
* Irregular astigmatism.
* History of chronic intraocular inflammation.
* History of retinal detachment.
* Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
* Previous intraocular surgery.
* Previous refractive surgery.
* Previous keratoplasty
* Severe dry eye
* Pupil abnormalities
* 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)
* Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
* 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.
* 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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Carolina Eyecare Physicians, LLC
OTHER
Responsible Party
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Principal Investigators
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Kerry D Solomon
Role: PRINCIPAL_INVESTIGATOR
Carolina Eyecare Physicians
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 21-001
Identifier Type: -
Identifier Source: org_study_id
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