Monofocal IOL Visual Outcomes When Targeting Mini Monovision

Sponsor
Carolina Eyecare Physicians, LLC (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05069415
Collaborator
(none)
74
2
2
11.9
37
3.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Eyhance IOL
  • Device: Eyhance IOL
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens
Actual Study Start Date :
Oct 4, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Binocular low contrast distance visual acuity at 3 months [3 months]

  2. Distance-corrected near visual acuity at best distance at 3 months [3 months]

  3. Spectacle Independence Questionnaire [3 months]

    Participants will answer a questionnaire to determine the need for glasses for near activities

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Sight Sarasota Florida United States 34239
2 Carolina Eyecare Physicians, LLC Mount Pleasant South Carolina United States 29464

Sponsors and Collaborators

  • Carolina Eyecare Physicians, LLC

Investigators

  • Principal Investigator: Kerry D Solomon, Carolina Eyecare Physicians

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carolina Eyecare Physicians, LLC
ClinicalTrials.gov Identifier:
NCT05069415
Other Study ID Numbers:
  • CEP 21-001
First Posted:
Oct 6, 2021
Last Update Posted:
Jun 9, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2022