Status:
COMPLETED
Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens
Lead Sponsor:
Gainesville Eye Associates
Collaborating Sponsors:
Sengi
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 10 2025
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06122103
Start Date
November 21 2023
End Date
February 10 2025
Last Update
March 13 2025
Active Locations (1)
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1
Gainesville Eye Associates
Gainesville, Georgia, United States, 30501