N/A
N=75
Monofocal IOL Visual Outcomes When Targeting Mini Monovision
Cataract · Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT05069415 ↗Enrolled (actual)
75
Serious AEs
2.8%
Results posted
Feb 2024
Primary outcome: Primary: Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months. — 0.19; 0.04 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Eyhance IOL (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Carolina Eyecare Physicians, LLC
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months. |
0.19; 0.04 | — |
| SECONDARY Binocular Low Contrast Distance Visual Acuity at 3 Months |
0.15; 0.15 | — |
| SECONDARY Distance-corrected Near Visual Acuity at Best Distance at 3 Months |
0.43; 0.21 | — |
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.
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT05069415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.