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

Sponsor

East Coast Institute for Research (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05827133

Collaborator

Alcon Research (Industry), Florida Eye Specialists (Other)

100

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Lenses, Intraocular	Other: No intervention

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Crossover

Time Perspective:

Cross-Sectional

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)	Other: No intervention No intervention

Arm

Intervention/Treatment

Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

Monocular best-corrected distance visual acuity (BCDVA) (4 m) (logMAR) [Visit 1]

Secondary Outcome Measures

Decentration of intraocular lens (IOL) (mm) [Visit 1]
Tilt of intraocular lens (IOL) (°) [Visit 1]
Monocular uncorrected distance visual acuity (UCDVA) (4 m) (logMAR) [Visit 1]
Monocular distance-corrected intermediate visual acuity (DCIVA) (66 cm) (logMAR) [Visit 1]
Monocular uncorrected intermediate visual acuity (UCIVA) (66 cm) (logMAR) [Visit 1]
Manifest refraction/Manifest refraction spherical equivalent (MRSE) (D) [Visit 1]

Other Outcome Measures

Mean photopic low contrast (25%) monocular best-corrected distance visual acuity (BDCVA) (4 m) (logMAR) [Visit 1]
Mesopic pupil size (mm) [Visit 1]
Coma higher-order aberration (HOA) (µm) [Visit 1]
Spherical higher-order aberration (HOA) (µm) [Visit 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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