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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05226884
Other study ID # 69901155
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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