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Monofocal IOL Visual Outcomes When Targeting Mini Monovision

Primary Purpose

Cataract, Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eyhance IOL
Eyhance IOL
Sponsored by
Carolina Eyecare Physicians, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Sight
  • Carolina Eyecare Physicians, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Emmetropia

Mini monovision

Arm Description

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

The target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15.

Outcomes

Primary Outcome Measures

Binocular distance-corrected intermediate (66 cm) visual acuity at 3 months.

Secondary Outcome Measures

Binocular low contrast distance visual acuity at 3 months
Distance-corrected near visual acuity at best distance at 3 months
Spectacle Independence Questionnaire
Participants will answer a questionnaire to determine the need for glasses for near activities

Full Information

First Posted
September 13, 2021
Last Updated
February 15, 2023
Sponsor
Carolina Eyecare Physicians, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05069415
Brief Title
Monofocal IOL Visual Outcomes When Targeting Mini Monovision
Official Title
Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carolina Eyecare Physicians, LLC

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Presbyopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emmetropia
Arm Type
Active Comparator
Arm Description
The target refraction for both eyes will be emmetropia (± 0.25 D).
Arm Title
Mini monovision
Arm Type
Experimental
Arm Description
The target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15.
Intervention Type
Device
Intervention Name(s)
Eyhance IOL
Intervention Description
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.
Intervention Type
Device
Intervention Name(s)
Eyhance IOL
Intervention Description
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.
Primary Outcome Measure Information:
Title
Binocular distance-corrected intermediate (66 cm) visual acuity at 3 months.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Binocular low contrast distance visual acuity at 3 months
Time Frame
3 months
Title
Distance-corrected near visual acuity at best distance at 3 months
Time Frame
3 months
Title
Spectacle Independence Questionnaire
Description
Participants will answer a questionnaire to determine the need for glasses for near activities
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry D Solomon
Organizational Affiliation
Carolina Eyecare Physicians
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Sight
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Carolina Eyecare Physicians, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Monofocal IOL Visual Outcomes When Targeting Mini Monovision

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