Cataract, Presbyopia
Conditions
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.
Interventions
DEVICEEyhance IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.
Sponsors
Carolina Eyecare Physicians, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Binocular Low Contrast Distance Visual Acuity at 3 Months | 3 months |
| Distance-corrected Near Visual Acuity at Best Distance at 3 Months | 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| 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. | 37 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Mini Monovision | Total | Emmetropia |
|---|---|---|---|
| Age, Continuous | 69.5 years STANDARD_DEVIATION 4.3 | 69.8 years STANDARD_DEVIATION 5.3 | 70.1 years STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 58 Participants | 29 Participants |
| Sex: Female, Male Female | 23 Participants | 44 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 27 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 37 |
| other Total, other adverse events | 0 / 34 | 0 / 37 |
| serious Total, serious adverse events | 2 / 34 | 0 / 37 |
Outcome results
Primary
Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emmetropia | Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months. | 0.19 logMAR | Standard Deviation 0.16 |
| Mini Monovision | Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months. | 0.04 logMAR | Standard Deviation 0.1 |
Secondary
Binocular Low Contrast Distance Visual Acuity at 3 Months
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emmetropia | Binocular Low Contrast Distance Visual Acuity at 3 Months | 0.15 logMAR | Standard Deviation 0.09 |
| Mini Monovision | Binocular Low Contrast Distance Visual Acuity at 3 Months | 0.15 logMAR | Standard Deviation 0.13 |
Secondary
Distance-corrected Near Visual Acuity at Best Distance at 3 Months
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emmetropia | Distance-corrected Near Visual Acuity at Best Distance at 3 Months | 0.43 logMAR | Standard Deviation 0.18 |
| Mini Monovision | Distance-corrected Near Visual Acuity at Best Distance at 3 Months | 0.21 logMAR | Standard Deviation 0.15 |