Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05226884

Enrollment

310

Registered

2022-02-07

Start date

2021-11-30

Completion date

2022-08-06

Last updated

2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudophakia

Keywords

Clareon, Eyhance, pseudophakia

Brief summary

Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.

Detailed description

This is a non-interventional prospective, comparative study of the outcomes for patients following successful, uncomplicated cataract surgery. All patients will have had bilateral implantation of an Eyhance IOL (DIB00/DIU\*\*\*) or Clareon IOL (CNA0T0) at the time of uncomplicated cataract surgery. These patients will then be assessed post-operatively to compare distance and intermediate visual acuities and a defocus curve in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs. Patients will be assessed for corrected binocular distance and intermediate vision.

Interventions

DIAGNOSTIC_TESTVisual Acuity

Measurement of distance and intermediate visual acuity at variety targeted correction.

DIAGNOSTIC_TESTDefocus Curve

Measurement of a defocus curve

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Adults, 40 years of age having already undergone uncomplicated cataract removal by phacoemulsification with a clear corneal incision in both eyes. 2. Implantation of bilateral Clareon intraocular lenses or Eyhance intraocular lenses (DIB00/DIU\*\*\*). 3. Able to comprehend and willing to sign informed consent and complete all required testing procedures 4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better 5. Clear intraocular media 6. Minimum of two weeks post yttrium aluminum garnet laser capsulotomy to treat PCO

Exclusion criteria

1. Any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study 2. Any complication during cataract surgery (capsular tear, vitrectomy, etc) 3. History of or current retinal conditions in either eye that would confound the results of this investigation in the opinion of the investigator (e.g. retinal detachment, epiretinal membrane, retinal ischemia, retinal inflammation, etc) 4. Amblyopia or strabismus in either eye 5. History of or current anterior or posterior segment inflammation of any etiology 6. Any form of neovascularization on or within the eye 7. Glaucoma (uncontrolled or controlled with medication) 8. Optic nerve atrophy 9. Subjects with diagnosed degenerative eye disorders 10. Postoperative CDVA worse than 0.10 logMAR (20/25 snellen) in either eye. 11. Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)

Design outcomes

Primary

Measure	Time frame	Description
Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Distance 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.
Binocular Distance Corrected Defocus Curve	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	The 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.
Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Target-corrected binocular distance (4 m) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Target-corrected binocular intermediate (66 cm) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
Non-inferiority of Best Corrected Distance Visual Acuity	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Comparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon subjects versus Eyhance subjects.

Secondary

Measure	Time frame	Description
Postoperative Residual Astigmatism	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Comparison of the amount of residual astigmatism of Clareon subjects versus Eyhance subjects.
Post-operative Spherical Equivalent	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Comparison of the Post-operative Spherical Equivalent of Clareon subjects versus Eyhance subjects.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	155
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.	155
Total	310

Baseline characteristics

Characteristic	Eyhance IOL Group	Clareon IOL Group	Total
Age, Continuous	69.54 years STANDARD_DEVIATION 6.85	69.26 years STANDARD_DEVIATION 6.61	69.45 years STANDARD_DEVIATION 6.73
Anterior Chamber Depth	3.23 millimeters STANDARD_DEVIATION 0.39	3.13 millimeters STANDARD_DEVIATION 0.39	3.18 millimeters STANDARD_DEVIATION 0.39
Average Corneal Power	43.01 Diopters STANDARD_DEVIATION 1.85	43.48 Diopters STANDARD_DEVIATION 1.49	43.25 Diopters STANDARD_DEVIATION 1.67
Axial Length	24.27 millimeters STANDARD_DEVIATION 1.41	23.81 millimeters STANDARD_DEVIATION 1.07	24.04 millimeters STANDARD_DEVIATION 1.24
Corneal Astigmatism	43.08 diopters STANDARD_DEVIATION 1.85	43.48 diopters STANDARD_DEVIATION 1.49	43.28 diopters STANDARD_DEVIATION 1.67
IOL Power	19.77 Diopters STANDARD_DEVIATION 4.01	20.52 Diopters STANDARD_DEVIATION 2.86	20.15 Diopters STANDARD_DEVIATION 3.44
Predicted Post-operative Spherical Equivalent	-0.35 diopters STANDARD_DEVIATION 0.52	-0.32 diopters STANDARD_DEVIATION 0.36	-0.34 diopters STANDARD_DEVIATION 0.44
Pupil Size	3.79 millimeters STANDARD_DEVIATION 0.86	3.61 millimeters STANDARD_DEVIATION 0.88	3.7 millimeters STANDARD_DEVIATION 0.87
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	3 Participants	6 Participants	9 Participants
Race (NIH/OMB) Black or African American	16 Participants	52 Participants	68 Participants
Race (NIH/OMB) More than one race	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	134 Participants	94 Participants	228 Participants
Region of Enrollment United States	155 participants	155 participants	310 participants
Sex: Female, Male Female	85 Participants	100 Participants	185 Participants
Sex: Female, Male Male	70 Participants	55 Participants	125 Participants
Target/Aim	-0.29 diopters STANDARD_DEVIATION 0.51	-0.29 diopters STANDARD_DEVIATION 0.32	-0.29 diopters STANDARD_DEVIATION 0.42

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 155	0 / 155
other Total, other adverse events	0 / 155	0 / 155
serious Total, serious adverse events	0 / 155	0 / 155

Outcome results

Primary

Binocular Distance Corrected Defocus Curve

The 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.