Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

Pseudophakia Clinical Trial

Official title:

Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064916
• Other study ID #: 69865263
• Status: Recruiting
• Start date: July 25, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Berkeley Eye Center
• Contact: Diana Hill
• Phone: 713-620-7640
• Email: diana.hill[@]berkeleyeye.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• 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 cataract removal by phacoemulsification with a clear corneal incision in both eyes with implantation of the Vivity IOL (DAT***/CCWET*)

2. 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

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 YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)

7. Residual refractive astigmatism =0.50 diopters

8. Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent

Exclusion Criteria:

1. 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

2. Any complication during cataract surgery (capsular tear, vitrectomy, etc)

3. History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions

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 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 principal investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)

Related Conditions & MeSH terms

• Pseudophakia

Intervention

Diagnostic Test:
• Visual Acuity
Monocular and binocular measurement of distance, intermediate, and near visual acuity
• Defocus Curve
Measurement of a defocus curve

Other:
• Intraocular Lens Satisfaction (IOLSAT) Questionnaire
Self-reported post-operative patient satisfaction with vision after surgery
• Quality of Vision After Surgery (QUVID) Questionnaire
Self-reported post-operative patient vision quality after surgery
• 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

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
Other	Binocular BCDVA under mesopic room lighting conditions	Binocular BCDVA under mesopic room lighting conditions	3 weeks post operatively
Other	Any spherical aberration changes pre cataract surgery and post cataract surgery	Any spherical aberration changes pre cataract surgery and post cataract surgery	3 weeks post operatively
Other	Binocular defocus curve	Binocular defocus curve	3 weeks post operatively
Other	Spectacle independence (IOLSAT)	Spectacle independence (IOLSAT)	3 weeks post operatively
Primary	Binocular Best Corrected Distance Visual Acuity	Binocular Best Corrected Distance Visual Acuity	3 weeks post operatively
Secondary	Monocular vision	Monocular UCDVA (uncorrected distance visual acuity), UCIVA (uncorrected intermediate visual acuity), UCNVA (uncorrected near visual acuity), and BCDVA (best corrected distance visual acuity)	3 weeks post operatively
Secondary	Binocular distance, intermediate, and near visual acuity	Binocular distance, intermediate, and near visual acuity	3 weeks post operatively
Secondary	Self-reported visual disturbances	Self-reported visual disturbances	3 weeks post operatively
Secondary	Quality of Vision After Surgery (QUVID) questionnaire	Patient self-reported satisfaction and quality of vision	3 weeks post operatively
Secondary	Intraocular Lens Satisfaction (IOLSAT) questionnaire	Patient self-reported satisfaction and quality of vision	3 weeks post operatively
Secondary	Post-op refraction	Post-op refraction	3 weeks post operatively