Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

Pseudophakia Clinical Trial

Official title:

Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05226884
• Other study ID #: 69901155
• Status: Completed
• Start date: November 30, 2021
• Est. completion date: August 6, 2022

Study information

• Verified date: November 2022
• 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, 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 determine binocular intermediate vision. Patients will be assessed for corrected binocular distance and intermediate vision.

Description:

This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, two-arm comparative study of the outcomes for patients following successful, uncomplicated cataract surgery. 155 subjects will be enrolled in each arm of the study, with 310 total subjects. 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 determine binocular intermediate vision. Patients will be assessed for corrected binocular distance and intermediate vision at plano for the Eyhance group and -0.25D for Clareon group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: August 6, 2022
• Est. primary completion date: August 6, 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 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)

Related Conditions & MeSH terms

• Pseudophakia

Intervention

Diagnostic Test:
• Visual Acuity
Measurement of distance and intermediate visual acuity at variety targeted correction.
• Defocus Curve
Measurement of a defocus curve

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
Primary	Distance target-corrected binocular intermediate (66 cm) visual acuity	Distance target-corrected binocular intermediate (66 cm) visual acuity of Clareon subjects at -0.25 sphere and the Eyhance subjects plano sphere.	minimum of 3 weeks post operatively
Secondary	Binocular target corrected defocus curve	Binocular target corrected defocus curve	minimum of 3 weeks post operatively