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

Sponsor
Gainesville Eye Associates (Other)
Overall Status
Recruiting
CT.gov ID
NCT04936256
Collaborator
Sengi (Other)
30
1
11
2.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Clareon

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens
Actual Study Start Date :
Jul 2, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Bilateral implantation of the Clareon monofocal IOL

Clareon monofocal intraocular lens (IOL)

Device: Clareon
Clareon monofocal intraocular lens (IOL)

Outcome Measures

Primary Outcome Measures

  1. Refractive stability [3 months]

    Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months)

Secondary Outcome Measures

  1. Binocular uncorrected distance visual acuity [3 months]

    Binocular uncorrected distance visual acuity

  2. Binocular uncorrected intermediate visual acuity [3 months]

    Binocular uncorrected intermediate visual acuity

  3. Binocular best-corrected distance visual acuity [3 months]

    Binocular best-corrected distance visual acuity

  4. Binocular best-corrected intermediate visual acuity [3 months]

    Binocular best-corrected intermediate visual acuity

  5. Binocular defocus curve [3 months]

    Binocular defocus curve

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gainesville Eye Associates Gainesville Georgia United States 30501

Sponsors and Collaborators

  • Gainesville Eye Associates
  • Sengi

Investigators

  • Principal Investigator: Clayton Blehm, MD, Gainesville Eye Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gainesville Eye Associates
ClinicalTrials.gov Identifier:
NCT04936256
Other Study ID Numbers:
  • CB-20-001
First Posted:
Jun 23, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Jul 1, 2021
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.:
No
Keywords provided by Gainesville Eye Associates
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021