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OpenTrials
Completed

NCT Number: NCT06122103

Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens

This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gainesville Eye Associates

Gainesville, Georgia, 30501, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.

  • Adult patients undergoing age-related cataract surgery with expected best- corrected visual outcomes of 20/25 or better
  • Regular corneal astigmatism of 0.75D-2.50D
  • Dilated pupil diameter of 7mm or greater

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.

  • Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, history of uveitis, ocular herpes simplex virus, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
  • History of corneal refractive and intraocular surgery.
  • Patients taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina.

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.

Treatment and study plan

Clareon monofocal

Device

Clareon Monofocal Intraocular Lens (toric and non-toric)

Light-Adjustable Lens

Device

Light-Adjustable Lens (Intraocular Lens)

Primary outcomes

  1. Binocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 3 months postop

Secondary outcomes

  1. Binocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 3 months postop

  2. Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)

    Time frame: 3 months postop

  3. Binocular Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 3 months postop

  4. Monocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 3 months postop

  5. Monocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 3 months postop

  6. Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)

    Time frame: 3 months postop

  7. Monocular Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 3 months postop

Other outcomes

  1. Binocular Distance-corrected Near Visual Acuity (DCNVA)

    Time frame: 3 months postop

  2. Binocular Uncorrected Near Visual Acuity (UNVA)

    Time frame: 3 months postop

  3. Monocular Distance Corrected Defocus Curve

    Time frame: 3 months postop

  4. Binocular Distance Corrected Defocus Curve

    Time frame: 3 months postop

  5. Manifest Refraction

    Time frame: 3 months postop

    MRSE, residual sphere, and residual astigmatism

  6. Patient Reported Spectacle Usage Questionnaire (PRSIQ)

    Time frame: 3 months postop

    Participants are asked to indicate spectacle usage on a scale of "All of the time" to "None of the time" for distance, intermediate, and near vision.

  7. Wavefront Aberrometry Using iTrace (Internal, Ocular, and Corneal Total Higher Order Aberrations)

    Time frame: 3 months postop

    Aberrometry was performed using the iTrace (Tracy Technologies, USA)

Sponsors and collaborators

Lead sponsor

Gainesville Eye Associates

Other

Collaborators

  • Sengi

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2023
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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