Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
Study Details
Study Description
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 implantation of the Vivity IOL (DAT***/CCWET*).
Patients will be assessed for monocular and binocular distance, intermediate, and near vision.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 surgery with bilateral implantation of the Vivity IOL (DAT***/CCWET*) performed by 4 surgeons using similar surgical techniques. 40 subjects will be enrolled.
Patients will be assessed for monocular and binocular distance, intermediate, and near vision.
The hypothesis is that post-refractive patients that have high spherical aberration (SAs) will have excellent outcomes and satisfaction with a Vivity IOL
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Vivity IOL Group Patients with bilateral implantation of Vivity IOLs. |
Diagnostic Test: Visual Acuity
Monocular and binocular measurement of distance, intermediate, and near visual acuity
Diagnostic Test: Defocus Curve
Measurement of a defocus curve
Other: Intraocular Lens Satisfaction (IOLSAT) Questionnaire
Self-reported post-operative patient satisfaction with vision after surgery
Other: Quality of Vision After Surgery (QUVID) Questionnaire
Self-reported post-operative patient vision quality after surgery
Other: Visual Disturbance Questionnaire
Questionnaire of self-reported visual disturbances of patients
Diagnostic Test: Topography and Tomography
Topography and tomography measurements with Atlas, iTrace, and/or Pentacam
|
Outcome Measures
Primary Outcome Measures
- Binocular Best Corrected Distance Visual Acuity [3 weeks post operatively]
Binocular Best Corrected Distance Visual Acuity
Secondary Outcome Measures
- Monocular vision [3 weeks post operatively]
Monocular UCDVA (uncorrected distance visual acuity), UCIVA (uncorrected intermediate visual acuity), UCNVA (uncorrected near visual acuity), and BCDVA (best corrected distance visual acuity)
- Binocular distance, intermediate, and near visual acuity [3 weeks post operatively]
Binocular distance, intermediate, and near visual acuity
- Self-reported visual disturbances [3 weeks post operatively]
Self-reported visual disturbances
- Quality of Vision After Surgery (QUVID) questionnaire [3 weeks post operatively]
Patient self-reported satisfaction and quality of vision
- Intraocular Lens Satisfaction (IOLSAT) questionnaire [3 weeks post operatively]
Patient self-reported satisfaction and quality of vision
- Post-op refraction [3 weeks post operatively]
Post-op refraction
Other Outcome Measures
- Binocular BCDVA under mesopic room lighting conditions [3 weeks post operatively]
Binocular BCDVA under mesopic room lighting conditions
- Any spherical aberration changes pre cataract surgery and post cataract surgery [3 weeks post operatively]
Any spherical aberration changes pre cataract surgery and post cataract surgery
- Binocular defocus curve [3 weeks post operatively]
Binocular defocus curve
- Spectacle independence (IOLSAT) [3 weeks post operatively]
Spectacle independence (IOLSAT)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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*)
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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
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Able to comprehend and willing to sign informed consent and complete all required testing procedures
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Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
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Clear intraocular media
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Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
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Residual refractive astigmatism ≤0.50 diopters
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Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent
Exclusion Criteria:
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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
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Any complication during cataract surgery (capsular tear, vitrectomy, etc)
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History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
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Amblyopia or strabismus in either eye
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History of or current anterior or posterior segment inflammation of any etiology
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Any form of neovascularization on or within the eye
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Glaucoma (uncontrolled or controlled with medication)
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Optic nerve atrophy
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Subjects with diagnosed degenerative eye disorders
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Postoperative CDVA worse than 0.10 logMAR in either eye.
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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)
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.- 69865263