Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+

Not Applicable

Not yet recruiting

• Conditions: Cataract
• Interventions: Device: LAL+; Device: Clareon Vivity Toric IOL

• Registration Number: NCT06574646
• Lead Sponsor: The Eye Associates

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, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Subjects will be randomized in a 1:1 manner to LAL+ or Clareon VIvity Toric IOLs.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Study Start: 2024-10-15
• Primary Completion: 2026-02-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAL+	LAL+	-
Clareon Vivity Toric IOLs	Clareon Vivity Toric IOL	-

Primary Outcome Measures

Name	Time	Method
Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm	at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for LAL+ implanted subjects and >2 weeks post YAG, if done.	Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm

Trial Locations

Locations (1)

The Eye Associates of Manatee, LLP; 🇺🇸 Bradenton, Florida, United States