Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

• Sponsor: Berkeley Eye Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05226884
• Collaborator: (none)
• Enrollment: 310
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 25.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pseudophakia	Diagnostic Test: Visual Acuity; Diagnostic Test: Defocus Curve

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 310 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
• Actual Study Start Date: Nov 30, 2021
• Anticipated Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Clareon IOL Group Patients with bilateral implantation of Clareon IOLs.	Diagnostic Test: Visual Acuity; Measurement of distance and intermediate visual acuity at variety targeted correction.; Diagnostic Test: Defocus Curve; Measurement of a defocus curve
Eyhance IOL Group Patients with bilateral implantation of EyhanceIOLs.	Diagnostic Test: Visual Acuity; Measurement of distance and intermediate visual acuity at variety targeted correction.; Diagnostic Test: Defocus Curve; Measurement of a defocus curve

Outcome Measures

Primary Outcome Measures

1. Distance target-corrected binocular intermediate (66 cm) visual acuity [minimum of 3 weeks post operatively]

   Distance target-corrected binocular intermediate (66 cm) visual acuity of Clareon subjects at -0.25 sphere and the Eyhance subjects plano sphere.

Secondary Outcome Measures

1. Binocular target corrected defocus curve [minimum of 3 weeks post operatively]

   Binocular target corrected defocus curve

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Berkeley Eye Center	Houston	Texas	United States	77027

Sponsors and Collaborators

• Berkeley Eye Center

Investigators

• Principal Investigator: Morgan Micheletti, MD, Berkeley Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Berkeley Eye Center
• ClinicalTrials.gov Identifier: NCT05226884
• Other Study ID Numbers: 69901155
• First Posted: Feb 7, 2022
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Berkeley Eye Center: Clareon; Eyhance; pseudophakia
• Additional relevant MeSH terms: Pseudophakia

Study Results

No Results Posted as of Jul 13, 2022