Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens

Cataract Clinical Trial

Official title:

Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936256
• Other study ID #: CB-20-001
• Status: Completed
• Start date: July 2, 2021
• Est. completion date: July 28, 2022

Study information

• Verified date: July 2021
• Source: Gainesville Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective is to evaluate refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months).

Description:

This study is a single-arm, evaluator masked clinical evaluation study of refractive stability, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and defocus curve.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 28, 2022
• Est. primary completion date: July 28, 2022
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Presenting for uncomplicated bilateral cataract surgery and have an interest in an IOL option

• Gender: Males and Females.

• Age: 50 or older

• 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.

• Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)

• Potential postoperative visual acuity of (20/25 Snellen) or better in both eyes

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Irregular astigmatism (e.g. keratoconus)

• Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)

• Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)

• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)

• Diabetic retinopathy

• Macular pathology (e.g. ARMD, ERM)

• History of retinal detachment

• Any patient based on Barrett toric calculator that will have = 0.75D residual astigmatism if Clareon® non-toric IOL is implanted

• Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity

• Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating)

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Clareon
Clareon monofocal intraocular lens (IOL)

Locations

Country	Name	City	State
United States	Gainesville Eye Associates	Gainesville	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Gainesville Eye Associates	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refractive stability	Refractive stability (spherical equivalent change = 0.50D from 1-month to 3-months)	3 months
Secondary	Binocular uncorrected distance visual acuity	Binocular uncorrected distance visual acuity	3 months
Secondary	Binocular uncorrected intermediate visual acuity	Binocular uncorrected intermediate visual acuity	3 months
Secondary	Binocular best-corrected distance visual acuity	Binocular best-corrected distance visual acuity	3 months
Secondary	Binocular best-corrected intermediate visual acuity	Binocular best-corrected intermediate visual acuity	3 months
Secondary	Binocular defocus curve	Binocular defocus curve	3 months