Maximizing Visual Outcomes With Eyhance IOLs

Pseudophakia Clinical Trial

Official title:

Maximizing Visual Outcomes With Eyhance IOLs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05611073
• Other study ID #: JMM-1261
• Status: Completed
• Start date: March 7, 2022
• Est. completion date: November 7, 2022

Study information

• Verified date: September 2023
• Source: Berkeley Eye Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 7, 2022
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Pseudophakia

Intervention

Diagnostic Test:
• 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.

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

Locations

Country	Name	City	State
United States	Berkeley Eye Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Berkeley Eye Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	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.	minimum of 3 weeks post operatively
Primary	Comparison of two groups categorized by "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.	To compare two groups categorized by "distance with minimal intermediate" and "distance with enhanced intermediate/near" based on mean photopic binocular BCDVA and DCIVA (66 cm) of patients with bilateral Eyhance IOLs targeted corrected at plano sphere.	minimum of 3 weeks post operatively
Secondary	Determine if any statistically significant differences in pupil size exists between the two groups.	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.	minimum of 3 weeks post operatively
Secondary	Determine if any statistically significant differences in spherical aberration exists between the two groups.	To determine if any statistically significant differences in spherical aberration 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.	minimum of 3 weeks post operatively
Secondary	Determine if any statistically significant differences in q value exists between the two groups.	To determine if any statistically significant differences in q value 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.	minimum of 3 weeks post operatively
Secondary	Determine if any statistically significant differences in biometric data exists between the two groups.	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.	minimum of 3 weeks post operatively