Trial Outcomes & Findings for Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs (NCT NCT05226884)
NCT ID: NCT05226884
Last Updated: 2024-11-15
Results Overview
Target-corrected binocular intermediate (66 cm) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
Recruitment status
COMPLETED
Target enrollment
310 participants
Primary outcome timeframe
Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Results posted on
2024-11-15
Participant Flow
Participant milestones
| Measure |
Clareon IOL Group
Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
Eyhance IOL Group
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
155
|
|
Overall Study
COMPLETED
|
155
|
155
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
Baseline characteristics by cohort
| Measure |
Clareon IOL Group
n=155 Participants
Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
Eyhance IOL Group
n=155 Participants
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.26 years
STANDARD_DEVIATION 6.61 • n=99 Participants
|
69.54 years
STANDARD_DEVIATION 6.85 • n=107 Participants
|
69.45 years
STANDARD_DEVIATION 6.73 • n=206 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
185 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=99 Participants
|
155 participants
n=107 Participants
|
310 participants
n=206 Participants
|
|
Axial Length
|
23.81 millimeters
STANDARD_DEVIATION 1.07 • n=99 Participants
|
24.27 millimeters
STANDARD_DEVIATION 1.41 • n=107 Participants
|
24.04 millimeters
STANDARD_DEVIATION 1.24 • n=206 Participants
|
|
IOL Power
|
20.52 Diopters
STANDARD_DEVIATION 2.86 • n=99 Participants
|
19.77 Diopters
STANDARD_DEVIATION 4.01 • n=107 Participants
|
20.15 Diopters
STANDARD_DEVIATION 3.44 • n=206 Participants
|
|
Corneal Astigmatism
|
43.48 diopters
STANDARD_DEVIATION 1.49 • n=99 Participants
|
43.08 diopters
STANDARD_DEVIATION 1.85 • n=107 Participants
|
43.28 diopters
STANDARD_DEVIATION 1.67 • n=206 Participants
|
|
Anterior Chamber Depth
|
3.13 millimeters
STANDARD_DEVIATION 0.39 • n=99 Participants
|
3.23 millimeters
STANDARD_DEVIATION 0.39 • n=107 Participants
|
3.18 millimeters
STANDARD_DEVIATION 0.39 • n=206 Participants
|
|
Pupil Size
|
3.61 millimeters
STANDARD_DEVIATION 0.88 • n=99 Participants
|
3.79 millimeters
STANDARD_DEVIATION 0.86 • n=107 Participants
|
3.7 millimeters
STANDARD_DEVIATION 0.87 • n=206 Participants
|
|
Target/Aim
|
-0.29 diopters
STANDARD_DEVIATION 0.32 • n=99 Participants
|
-0.29 diopters
STANDARD_DEVIATION 0.51 • n=107 Participants
|
-0.29 diopters
STANDARD_DEVIATION 0.42 • n=206 Participants
|
|
Predicted Post-operative Spherical Equivalent
|
-0.32 diopters
STANDARD_DEVIATION 0.36 • n=99 Participants
|
-0.35 diopters
STANDARD_DEVIATION 0.52 • n=107 Participants
|
-0.34 diopters
STANDARD_DEVIATION 0.44 • n=206 Participants
|
|
Average Corneal Power
|
43.48 Diopters
STANDARD_DEVIATION 1.49 • n=99 Participants
|
43.01 Diopters
STANDARD_DEVIATION 1.85 • n=107 Participants
|
43.25 Diopters
STANDARD_DEVIATION 1.67 • n=206 Participants
|
PRIMARY outcome
Timeframe: Minimum of 3 months post-operatively from cataract surgery, up to 2 yearsTarget-corrected binocular intermediate (66 cm) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
Outcome measures
| Measure |
Clareon IOL Group
n=155 Participants
Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
Eyhance IOL Group
n=155 Participants
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
|---|---|---|
|
Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset
|
0.20 LogMAR
Standard Deviation 0.1
|
0.19 LogMAR
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: Minimum of 3 months post-operatively from cataract surgery, up to 2 yearsDistance corrected binocular intermediate visual acuity (measured at 66 cm) of Clareon subjects versus Eyhance subjects with both groups set at plano sphere. Non-inferiority defined as 1 line.
Outcome measures
| Measure |
Clareon IOL Group
n=155 Participants
Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
Eyhance IOL Group
n=155 Participants
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
|---|---|---|
|
Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity
|
0.24 LogMAR
Standard Deviation 0.11
|
0.19 LogMAR
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: Minimum of 3 months post-operatively from cataract surgery, up to 2 yearsComparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon subjects versus Eyhance subjects.
Outcome measures
| Measure |
Clareon IOL Group
n=155 Participants
Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
Eyhance IOL Group
n=155 Participants
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
|---|---|---|
|
Non-inferiority of Best Corrected Distance Visual Acuity
|
0.01 LogMAR
Standard Deviation 0.02
|
0.02 LogMAR
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: Minimum of 3 months post-operatively from cataract surgery, up to 2 yearsThe Binocular Distance Corrected Defocus Curve measures visual acuity across simulated distances (+1.0D to -3.0D) in subjects with intraocular lenses (IOLs) post-cataract surgery. Testing begins with the best corrected visual acuity (BCVA), and the patient's refractive error is entered into the phoropter as the 0 position. Defocus lenses are introduced in 0.5D increments to simulate various distances. Visual acuity is measured binocularly at each level using standardized charts (e.g., ETDRS, Snellen) and recorded in logMAR. Measurements are taken at least 3 months post-op under standardized lighting conditions to evaluate visual performance across the defocus range in IOL patients.
Outcome measures
| Measure |
Clareon IOL Group
n=155 Participants
Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
Eyhance IOL Group
n=155 Participants
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
|---|---|---|
|
Binocular Distance Corrected Defocus Curve
-3.0 D
|
0.75 LogMAR
Standard Deviation 0.17
|
0.74 LogMAR
Standard Deviation 0.17
|
|
Binocular Distance Corrected Defocus Curve
-2.5 D
|
0.6 LogMAR
Standard Deviation 0.17
|
0.58 LogMAR
Standard Deviation 0.16
|
|
Binocular Distance Corrected Defocus Curve
-2.0 D
|
0.46 LogMAR
Standard Deviation 0.16
|
0.44 LogMAR
Standard Deviation 0.15
|
|
Binocular Distance Corrected Defocus Curve
-1.5 D
|
0.31 LogMAR
Standard Deviation 0.13
|
0.29 LogMAR
Standard Deviation 0.14
|
|
Binocular Distance Corrected Defocus Curve
-1.0 D
|
0.19 LogMAR
Standard Deviation 0.11
|
0.16 LogMAR
Standard Deviation 0.11
|
|
Binocular Distance Corrected Defocus Curve
-0.5 D
|
0.08 LogMAR
Standard Deviation 0.07
|
0.07 LogMAR
Standard Deviation 0.07
|
|
Binocular Distance Corrected Defocus Curve
-0.25 D
|
0.03 LogMAR
Standard Deviation .05
|
0.03 LogMAR
Standard Deviation .05
|
|
Binocular Distance Corrected Defocus Curve
0 D
|
0.01 LogMAR
Standard Deviation .02
|
0.02 LogMAR
Standard Deviation .03
|
|
Binocular Distance Corrected Defocus Curve
0.25 D
|
0.05 LogMAR
Standard Deviation .06
|
0.07 LogMAR
Standard Deviation 0.07
|
|
Binocular Distance Corrected Defocus Curve
0.5 D
|
0.14 LogMAR
Standard Deviation .08
|
0.16 LogMAR
Standard Deviation .1
|
|
Binocular Distance Corrected Defocus Curve
1 D
|
0.31 LogMAR
Standard Deviation .12
|
0.31 LogMAR
Standard Deviation .11
|
PRIMARY outcome
Timeframe: Minimum of 3 months post-operatively from cataract surgery, up to 2 yearsTarget-corrected binocular distance (4 m) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
Outcome measures
| Measure |
Clareon IOL Group
n=155 Participants
Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
Eyhance IOL Group
n=155 Participants
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
|---|---|---|
|
Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset
|
0.03 LogMAR
Standard Deviation 0.02
|
0.02 LogMAR
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Minimum of 3 months post-operatively from cataract surgery, up to 2 yearsComparison of the Post-operative Spherical Equivalent of Clareon subjects versus Eyhance subjects.
Outcome measures
| Measure |
Clareon IOL Group
n=155 Participants
Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
Eyhance IOL Group
n=155 Participants
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
|---|---|---|
|
Post-operative Spherical Equivalent
|
-0.04 Diopters
Standard Deviation 0.51
|
-0.04 Diopters
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Minimum of 3 months post-operatively from cataract surgery, up to 2 yearsComparison of the amount of residual astigmatism of Clareon subjects versus Eyhance subjects.
Outcome measures
| Measure |
Clareon IOL Group
n=155 Participants
Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
Eyhance IOL Group
n=155 Participants
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
|---|---|---|
|
Postoperative Residual Astigmatism
|
0.43 Diopters
Standard Deviation 0.44
|
0.36 Diopters
Standard Deviation 0.36
|
Adverse Events
Clareon IOL Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Eyhance IOL Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place