Gainesville Eye Associates
Gainesville, Georgia, 30501, United States
NCT Number: NCT06122103
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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Notify Me18 year and older
All sexes
Observational
Gainesville, Georgia, 30501, United States
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.
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.
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.
Clareon Monofocal Intraocular Lens (toric and non-toric)
Light-Adjustable Lens (Intraocular Lens)
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
Time frame: 3 months postop
MRSE, residual sphere, and residual astigmatism
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.
Time frame: 3 months postop
Aberrometry was performed using the iTrace (Tracy Technologies, USA)
Gainesville Eye Associates
Other
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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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