Status:
NOT_YET_RECRUITING
Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
Lead Sponsor:
The Eye Associates
Conditions:
Cataract
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs Phase 2 will be a prospective, ra...
Eligibility Criteria
Inclusion
- Adult (≥45) subjects who are astigmatic and require bilateral, routine small-incision, surgery for age-related cataracts with femtosecond laser;
- All subjects will be required to be targeted for refractive emmetropia (plano or first minus closest to plano);
- Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator;
- Subjects will have regular corneal astigmatism (1.00 to 2.00 D), which can be corrected with a toric power IOL of T3-T5;
- Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes;
Exclusion
- Moderate-severe corneal pathology;
- Irregular astigmatism;
- Subject desire monovision correction;
- Preexisting macular disease or other retinal degenerative diseases that is expected to cause future vision loss;
- History of glaucoma;
- Severe dry eye disease;
- History of uveitis;
- History of ocular herpes simplex virus;
- History of nystagmus;
- Zonular laxity or dehiscence;
- History psueudoexfoliation;
- History of corneal refractive and intraocular surgery or requiring any other planned ocular surgical procedures;
- Currently taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina;
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06574646
Start Date
October 15 2024
End Date
August 1 2026
Last Update
August 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Eye Associates of Manatee, LLP
Bradenton, Florida, United States, 34209