Monofocal IOL Visual Outcomes When Targeting Mini Monovision

Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens

This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia
• Intervention / Treatment: Device: Eyhance IOL; Device: Eyhance IOL

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Sarasota, Florida, United States, 34239
      • Center For Sight
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina EyeCare Physicians, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
• Willing and able to provide written informed consent for participation in the study
• Willing and able to comply with scheduled visits and other study procedures.
• Scheduled to undergo standard cataract surgery in both eyes within 6 - 30 days between surgeries.
• Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
• Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

• Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
• Uncontrolled diabetes.
• Use of any systemic or topical drug known to interfere with visual performance.
• Contact lens use during the active treatment portion of the trial.
• Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
• Clinically significant corneal dystrophy.
• Irregular astigmatism.
• History of chronic intraocular inflammation.
• History of retinal detachment.
• Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
• Previous intraocular surgery.
• Previous refractive surgery.
• Previous keratoplasty
• Severe dry eye
• Pupil abnormalities
• Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e. LASIK)
• Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
• Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
• Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Emmetropia; The target refraction for both eyes will be emmetropia (± 0.25 D).	Device: Eyhance IOL; Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.; Device: Eyhance IOL; Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.
Experimental: Mini monovision; The target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15.	Device: Eyhance IOL; Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.; Device: Eyhance IOL; Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Binocular Low Contrast Distance Visual Acuity at 3 Months	3 months
Distance-corrected Near Visual Acuity at Best Distance at 3 Months	3 months

Collaborators and Investigators

• Sponsor: Carolina Eyecare Physicians, LLC
• Investigators: Principal Investigator: Kerry D Solomon, Carolina Eyecare Physicians

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: CEP 21-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes