Monofocal IOL Visual Outcomes When Targeting Mini Monovision

Cataract Clinical Trial

Official title:

Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069415
• Other study ID #: CEP 21-001
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2024
• Source: Carolina Eyecare Physicians, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• Eyhance IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.
• Eyhance IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.

Locations

Country	Name	City	State
United States	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina
United States	Center for Sight	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Carolina Eyecare Physicians, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.		3 months
Secondary	Binocular Low Contrast Distance Visual Acuity at 3 Months		3 months
Secondary	Distance-corrected Near Visual Acuity at Best Distance at 3 Months		3 months