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

NCT ID: NCT06064916

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2024-12-11

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.

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

Conditions

Pseudophakia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Vivity IOL Group

Patients with bilateral implantation of Vivity IOLs.

Visual Acuity

Intervention Type: DIAGNOSTIC_TEST

Monocular and binocular measurement of distance, intermediate, and near visual acuity

Defocus Curve

Intervention Type: DIAGNOSTIC_TEST

Measurement of a defocus curve

Intraocular Lens Satisfaction (IOLSAT) Questionnaire

Intervention Type: OTHER

Self-reported post-operative patient satisfaction with vision after surgery

Quality of Vision After Surgery (QUVID) Questionnaire

Intervention Type: OTHER

Self-reported post-operative patient vision quality after surgery

Visual Disturbance Questionnaire

Intervention Type: OTHER

Questionnaire of self-reported visual disturbances of patients

Topography and Tomography

Intervention Type: DIAGNOSTIC_TEST

Topography and tomography measurements with Atlas, iTrace, and/or Pentacam

Interventions

Visual Acuity

Monocular and binocular measurement of distance, intermediate, and near visual acuity

Intervention Type: DIAGNOSTIC_TEST

Defocus Curve

Measurement of a defocus curve

Intervention Type: DIAGNOSTIC_TEST

Intraocular Lens Satisfaction (IOLSAT) Questionnaire

Self-reported post-operative patient satisfaction with vision after surgery

Intervention Type: OTHER

Quality of Vision After Surgery (QUVID) Questionnaire

Self-reported post-operative patient vision quality after surgery

Intervention Type: OTHER

Visual Disturbance Questionnaire

Questionnaire of self-reported visual disturbances of patients

Intervention Type: OTHER

Topography and Tomography

Topography and tomography measurements with Atlas, iTrace, and/or Pentacam

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Berkeley Eye Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morgan Micheletti, MD

Role: PRINCIPAL_INVESTIGATOR

Berkeley Eye Center

Locations

Berkeley Eye Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

69865263

Identifier Type: -

Identifier Source: org_study_id