Trial Outcomes & Findings for Monofocal IOL Visual Outcomes When Targeting Mini Monovision (NCT NCT05069415)
NCT ID: NCT05069415
Last Updated: 2024-02-13
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
3 months
Results posted on
2024-02-13
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
COMPLETED
|
34
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Monofocal IOL Visual Outcomes When Targeting Mini Monovision
Baseline characteristics by cohort
| Measure |
Emmetropia
n=34 Participants
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
n=37 Participants
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.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
69.8 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Emmetropia
n=34 Participants
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
n=37 Participants
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.
|
|---|---|---|
|
Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.
|
0.19 logMAR
Standard Deviation 0.16
|
0.04 logMAR
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Emmetropia
n=34 Participants
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
n=37 Participants
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.
|
|---|---|---|
|
Binocular Low Contrast Distance Visual Acuity at 3 Months
|
0.15 logMAR
Standard Deviation 0.09
|
0.15 logMAR
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Emmetropia
n=34 Participants
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
n=37 Participants
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.
|
|---|---|---|
|
Distance-corrected Near Visual Acuity at Best Distance at 3 Months
|
0.43 logMAR
Standard Deviation 0.18
|
0.21 logMAR
Standard Deviation 0.15
|
Adverse Events
Emmetropia
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Mini Monovision
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Emmetropia
n=34 participants at risk
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
n=37 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Central retinal vein occlusion
|
2.9%
1/34 • 3 months
|
0.00%
0/37 • 3 months
|
|
Eye disorders
Ischemic optic neuropathy
|
2.9%
1/34 • 3 months
|
0.00%
0/37 • 3 months
|
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
Carolina Eyecare Physicians, LLC
Phone: 8438813937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place