Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance With Clareon® Vivity® IOL Implantation

Cataract Clinical Trial

Official title:

A Non-Interventional Study to Evaluate the Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance in Patients Who Have Undergone Clareon® Vivity® IOL Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827133
• Other study ID #: ECIR-Alcon-01
• Status: Recruiting
• Start date: July 10, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: East Coast Institute for Research
• Contact: Rebecca Goldfaden, PharmD
• Phone: (904) 854-1354
• Email: rg[@]eastcoastresearch.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation.

The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision?

Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following:

• consent to participate in the study

• allow researchers to access their personal medical records

• undergo a series of tests to assess the position of their IOLs and quality of vision

Researchers will compare the patients' preoperative and postoperative test results to determine whether an association exists between IOL movement and patient quality of vision.

Description:

This is a non-interventional, single center, multi-surgeon, observational study to evaluate the effect of intraocular lens (IOL) centration and tilt on visual performance in patients who have undergone Clareon® Vivity® IOL implantation. The study population will include individuals implanted with Clareon® Vivity® and Vivity® Toric IOLs. IOL implantations reviewed will range from the earliest performed (May 2022) onward, until 100 implanted patients (200 eyes) are reached. Potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• History of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric intraocular lens (IOL) implantation with manifest refraction spherical equivalent (MRSE) within ±1.00 D

• Willing to undergo an eye exam with pupil dilation

Exclusion Criteria:

• Moderate to severe posterior capsule opacification (2+ or more)

• Yttrium aluminum garnet (YAG) laser capsulotomy within 1 month prior to enrollment

• Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) within the one year prior to IOL implantation or any time after IOL implantation

• Any previous ocular surgery (excluding YAG, LASIK, PRK)

• Clinically significant ocular pathology; severe diabetic retinopathy, age-related macular degeneration (AMD), glaucoma, severe dry eye, irregular astigmatism, zonular weakness, pseudoexfoliation, ocular trauma

• Any additional procedure(s) at the same time as the Vivity implantation including but not limited to microinvasive glaucoma surgery (MIGS)

• Women who are pregnant at the time of screening (based on self-reported history)

• Medical or other problems which in the opinion of the investigator will render study participation unsafe

Related Conditions & MeSH terms

• Cataract
• Lenses, Intraocular

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	East Coast Institute for Research	Jacksonville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
East Coast Institute for Research	Alcon Research, Florida Eye Specialists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean photopic low contrast (25%) monocular best-corrected distance visual acuity (BDCVA) (4 m) (logMAR)		Visit 1
Other	Mesopic pupil size (mm)		Visit 1
Other	Coma higher-order aberration (HOA) (µm)		Visit 1
Other	Spherical higher-order aberration (HOA) (µm)		Visit 1
Primary	Monocular best-corrected distance visual acuity (BCDVA) (4 m) (logMAR)		Visit 1
Secondary	Decentration of intraocular lens (IOL) (mm)		Visit 1
Secondary	Tilt of intraocular lens (IOL) (°)		Visit 1
Secondary	Monocular uncorrected distance visual acuity (UCDVA) (4 m) (logMAR)		Visit 1
Secondary	Monocular distance-corrected intermediate visual acuity (DCIVA) (66 cm) (logMAR)		Visit 1
Secondary	Monocular uncorrected intermediate visual acuity (UCIVA) (66 cm) (logMAR)		Visit 1
Secondary	Manifest refraction/Manifest refraction spherical equivalent (MRSE) (D)		Visit 1