NCT05069415

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 13, 2024

Completed
Last Updated

February 13, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

September 13, 2021

Results QC Date

January 19, 2024

Last Update Submit

January 19, 2024

Conditions

CataractPresbyopia

Outcome Measures

Primary Outcomes (1)

  • Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.

    3 months

Secondary Outcomes (2)

  • Binocular Low Contrast Distance Visual Acuity at 3 Months

    3 months

  • Distance-corrected Near Visual Acuity at Best Distance at 3 Months

    3 months

Study Arms (2)

Emmetropia

ACTIVE COMPARATOR

The target refraction for both eyes will be emmetropia (± 0.25 D).

Device: Eyhance IOL

Mini monovision

EXPERIMENTAL

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

Interventions

Eyhance IOLDEVICE

Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.

EmmetropiaMini monovision

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Sight

Sarasota, Florida, 34239, United States

Location

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Results Point of Contact

Title
Director of Clinical Trials
Organization
Carolina Eyecare Physicians, LLC
hps@cepmd.com
8438813937

Study Officials

  • Kerry D Solomon

    Carolina Eyecare Physicians

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

October 6, 2021

Study Start

October 4, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

February 13, 2024

Results First Posted

February 13, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)