NCT05069415
Completed
Not Applicable
Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Carolina Eyecare Physicians, LLC
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
- •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
- •Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic 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 nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 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.
- •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.
Outcomes
Primary Outcomes
Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.
Time Frame: 3 months
Secondary Outcomes
- Binocular Low Contrast Distance Visual Acuity at 3 Months(3 months)
- Distance-corrected Near Visual Acuity at Best Distance at 3 Months(3 months)
Study Sites (2)
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