Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119127
• Other study ID #: 63171943
• Status: Completed
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: August 19, 2021

Study information

• Verified date: November 2021
• Source: Central Florida Eye Specialists, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 19, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Alcon Vivity toric intra ocular lens
implanting vivity toric IOL to asses rotational stability. IOL is already FDA approved for implantation at time of cataract surger. Intervention is to assess rotational stability and visual outcome.

Locations

Country	Name	City	State
United States	Central Florida Eye Specialists	DeLand	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Kevin Barber	Alcon Research, Eric Rosenberg, D.O.,M.Sc.Eng.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rotational stability of Vivity Toric IOL.	Rotational stability of Vivity Toric IOL will be measured at post op 1 day, post op 1 week and post op 4 weeks.	Five months
Secondary	Percentage of eyes with residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities.	Percentage of eyes with post op rotation of five degrees or less, absolute prediction of error = 0.5 D, residual astigmatism = 0.5 D, residual astigmatism 1.00 D.; Monocular and Binocular UDVA, UIVA, UNVA, CDVA, DCIVA and DCNVA.	Five months