Maximizing Visual Outcomes With Eyhance IOLs

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05611073

Enrollment

110

Registered

2022-11-09

Start date

2022-03-07

Completion date

2022-11-07

Last updated

2025-05-23

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

Conditions

Pseudophakia

Keywords

Eyhance, Pseudophakia

Brief summary

Detailed description

This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had bilateral implantation of an Eyhance IOL at the time of cataract surgery. These patients will then be assessed in the 1-6-month post-operative period. Patients will be grouped into two arms: distance with minimal intermediate and distance with enhanced intermediate/near based on mean photopic binocular BCDVA and DCIVA (at 66 cm) of patients with bilateral Eyhance IOLs corrected to plano sphere. The distance with minimal intermediate group is defined by BCDVA of 0.1 logMAR or better but a DCIVA of 0.4 logMAR or worse. The distance with enhanced intermediate/near is defined by BCDVA of 0.1 logMAR or better and a DCIVA of 0.3 logMAR or better. In addition to binocular BCDVA and DCIVA, monocular measurements will be obtained as well. The two groups will be compared to assess which patient biometric properties (such as spherical aberration, q value, pupil size, etc.) lead to an overall increase in near or intermediate vision as well as overall patient satisfaction. Biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.

Interventions

DIAGNOSTIC_TESTVisual Acuity

Measurement of distance, intermediate and near visual acuity.

DIAGNOSTIC_TESTBiometric Data Collection

Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.

OTHERPatient Questionnaire

Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.

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 Eyhance IOLs (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 YAG 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 or predisposition to retinal conditions. 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). 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
Comparison of Two Groups Categorized by Distance With Minimal Intermediate and Distance With Enhanced Intermediate/Near Based on Mean Photopic Binocular DCIVA (at 66 cm) of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	To compare two groups categorized by distance with minimal intermediate and distance with enhanced intermediate/near based on mean photopic binocular DCIVA (66 cm) of patients with bilateral Eyhance IOLs targeted corrected at plano sphere.
Comparison of Two Groups Categorized by Distance With Minimal Intermediate and Distance With Enhanced Intermediate/Near Based on Mean Photopic Binocular BCDVA of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	To compare two groups categorized by distance with minimal intermediate and distance with enhanced intermediate/near based on mean photopic binocular BCDVA of patients with bilateral Eyhance IOLs targeted corrected at plano sphere.

Secondary

Measure	Time frame	Description
Spherical Aberration Between Groups	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	—
Biometric Data (Anterior Chamber Depth and Axial Length) Between Groups.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	To determine if any statistically significant differences in biometric data exists between the two groups that may allow for pre-operative recognition of those patients who could have enhanced benefits of the Eyhance IOL. This will require multiple regression analysis given the large number of variables.
Q Value Between Groups.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	Q-value is an assessment of corneal asphericity. * A value of 0 indicates a cornea that is perfectly spherical * A value between -1 and 0 indicates a cornea that is shaped more like a football * A value between 0 and 1 indicates a cornea that is shaped more like a dish
Determine if Any Statistically Significant Differences in Pupil Size Exists Between the Two Groups.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	To determine if any statistically significant differences in pupil size exists between the two groups that may allow for pre-operative recognition of those patients who could have enhanced benefits of the Eyhance IOL. This will require multiple regression analysis given the large number of variables.

Other

Measure	Time frame	Description
Comparison of a Patient Satisfaction Survey Between the Two Groups to Assess for Subjective Differences in Everyday Life. Patient's Answers Will be on a Scale Between Always and Never, Where Never Shows a Better Patient Outcome.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	Comparison of a patient satisfaction survey between the two groups to assess for subjective differences in everyday life to determine if the enhanced vision plays a statistically significant difference in patient's perceived quality of vision or quality of life. Patient's answers will be on a scale between always and never, where never shows a better patient outcome.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Distance With Minimal Intermediate Visual Acuity Group Patients with bilateral implantation of Eyhance IOLs. And defined by BCDVA of 0.1 logMAR or better but a DCIVA of 0.4 logMAR or worse. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace. Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.	49
Distance With Enhanced Intermediate/Near Visual Acuity Group Patients with bilateral implantation of Eyhance IOLS. And defined by BCDVA of 0.1 logMAR or better and a DCIVA of 0.3 logMAR or better. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace. Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.	61
Total	110

Baseline characteristics

Characteristic	Distance With Minimal Intermediate Visual Acuity Group	Distance With Enhanced Intermediate/Near Visual Acuity Group	Total
Age, Continuous	69.6 years STANDARD_DEVIATION 6.5	69.8 years STANDARD_DEVIATION 7.3	69.8 years STANDARD_DEVIATION 6.9
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	34 Participants	24 Participants	58 Participants
Sex: Female, Male Male	15 Participants	37 Participants	52 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 49	0 / 61
other Total, other adverse events	0 / 49	0 / 61
serious Total, serious adverse events	0 / 49	0 / 61

Outcome results

Primary

Comparison of Two Groups Categorized by Distance With Minimal Intermediate and Distance With Enhanced Intermediate/Near Based on Mean Photopic Binocular BCDVA of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere.

To compare two groups categorized by distance with minimal intermediate and distance with enhanced intermediate/near based on mean photopic binocular BCDVA of patients with bilateral Eyhance IOLs targeted corrected at plano sphere.