Clinical trial NCT05611073: Maximizing Visual Outcomes With Eyhance IOLs
Official title: Maximizing Visual Outcomes With Eyhance IOLs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudophakia
Keywords: Eyhance
Pseudophakia
Lead sponsor: Berkeley Eye Center
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance IOLs.

Brief summary: 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 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.

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: 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.
timeFrame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
measure: 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.
timeFrame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Secondary outcomes:
measure: Determine if Any Statistically Significant Differences in Pupil Size Exists Between the Two Groups.
timeFrame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
measure: Spherical Aberration Between Groups
timeFrame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
measure: Q Value Between Groups.
timeFrame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
measure: Biometric Data (Anterior Chamber Depth and Axial Length) Between Groups.
timeFrame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Other outcomes:
measure: 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.
timeFrame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Locations:
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
Study officials:
affiliation: Berkeley Eye Center
name: Morgan Micheletti, MD
role: PRINCIPAL_INVESTIGATOR
References: