Status:
COMPLETED
Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
Lead Sponsor:
Berkeley Eye Center
Conditions:
Pseudophakia
Eligibility:
All Genders
40+ years
Brief Summary
This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantat...
Detailed Description
This is a non-interventional, prospective, single center, bilateral, observational study of the outcomes for 40 post myopic refractive surgery patients following successful, uncomplicated cataract sur...
Eligibility Criteria
Inclusion
- Adults, 40 years of age having already undergone cataract removal by phacoemulsification with a clear corneal incision in both eyes with implantation of the Vivity IOL (DAT\*\*\*/CCWET\*)
- Prior uncomplicated, distance-targeted, bilateral myopic LASIK or PRK (photorefractive keratectomy) surgery and corneal spherical aberration greater than ≥0.30 μ and ≤ 1.20 μ in at least one eye (6.00 mm) as measured at their cataract pre-op visit
- Able to comprehend and willing to sign informed consent and complete all required testing procedures
- Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
- Clear intraocular media
- Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
- Residual refractive astigmatism ≤0.50 diopters
- Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent
Exclusion
- Any corneal abnormality, other than regular corneal astigmatism or myopic LASIK/PRK surgery, (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
- Any complication during cataract surgery (capsular tear, vitrectomy, etc)
- History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
- Amblyopia or strabismus in either eye
- History of or current anterior or posterior segment inflammation of any etiology
- Any form of neovascularization on or within the eye
- Glaucoma (uncontrolled or controlled with medication)
- Optic nerve atrophy
- Subjects with diagnosed degenerative eye disorders
- Postoperative CDVA worse than 0.10 logMAR in either eye.
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)
Key Trial Info
Start Date :
July 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06064916
Start Date
July 25 2023
End Date
December 11 2024
Last Update
May 23 2025
Active Locations (1)
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1
Berkeley Eye Center
Houston, Texas, United States, 77027