Clinical trial NCT05119127: Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.
Official title: The Purpose of This Research is to Assess Vivity Toric IOL Rotational Stability at the End of Surgery, Post op 1 Day, Post op 1 Week and Post op 4 Weeks. Participants in This Research Study Are 45 Years of Age or Older and Have Planned Implantation in at Least One Eye With an Acrysof IQ Vivity Extended Vision Toric IOL.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Vivity
Cataract
Intraocular lens
Lead sponsor: Central Florida Eye Specialists, LLC
Sponsor class: OTHER
Collaborators: name: Alcon Research
name: Eric Rosenberg, D.O.,M.Sc.Eng.
First posted: 2021-11-12
Enrollment: 35
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study will include adults (45 years and older) who plan to have cataract extraction and subsequent implantation of AcrySof® IQ Vivity™Extended Vision Toric IOL in at least one eye. Approximately 40 eye will be screened to identify 35 qualified eyes. Within 40 days of screening, qualified subjects will receive cataract surgery followed by implantation of the AcrySof® IQ Vivity™Extended Vision Toric IOL at the surgery visit. If the second eye will participate in the study, subjects will receive the second eye cataract surgery within 60 days of the Screening visit 0. Four postoperative follow up visits are planned to occur at 1-2 days, 7-14 days, and 28-35 days for each enrolled eye. Subject participation in this study is expected to last up to 2 months, including a total of 5 study visits for subjects implanted in one eye and up to 9 visits for subjects implanted in both eyes. Upon completion of the 35 day follow up visit subjects will be exited from the study.
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to assess the rotational stability of the AcrySof IQ Vivity Extended Vision Toric IOL and Refractive Visual outcome.

Detailed description: Assessment of the rotational stability and Refractive Visual Outcome of the AcrySof IQ Vivity Extended Vision Toric IOL at the end of surgery, post op 1 day, post op 1 week and post op 4 weeks. Participants in this research study are 45 years of age or older and have planned implantation in at least one eye.

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing cataract extraction with intraocular lens implantation.
* Age: 45 years and older.
* Willing and able to comply with scheduled visits and other study procedures.
* Subjects who require an IOL power in the range of +15.0 D to +25.0 D.
* Subjects with regular corneal astigmatism that can be treated with T3-T5.
* Have good ocular health, with no pathology that compromises visual acuity (Outside of residual refractive error and cataract)
* Potential postoperative visual acuity of 0.2 logMAR/ETDRS (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

* Glaucoma.
* Clinically significant corneal dystrophy.
* Previous corneal refractive surgery (i.e LASIK, PRK, RK)
* Pupil abnormalities.
* Concurrent infectious/non-infectious uveitis.
* History of chronic intraocular inflammation.
* Visually significant macular disease.
* History of retinal detachment.

Primary outcomes:
measure: Rotational stability of Vivity Toric IOL.
timeFrame: Five months
Secondary outcomes:
measure: Percentage of eyes with residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities.
timeFrame: Five months
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Central Florida Eye Specialists
state: Florida
Study officials:
affiliation: Ophthalmologist
name: Kevin Barber, MD
role: PRINCIPAL_INVESTIGATOR
References: