Trial Outcomes & Findings for Tolerance to Residual Astigmatism in Eyes With Vivity® (NCT NCT05392998)

Results Overview

Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x0\*, taking as a reference the subjects' axis

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

Three months after surgery

Results posted on

2024-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Vivity Patients The study included patients \>40 years old that underwent routine cataract surgery and IOL implantation. Exclusion criteria included corneal astigmatism ≥1.0 diopters (D), amblyopia, previous ocular surgery, and presence of ocular pathologies and abnormal iris. Patients with intra- or postoperative complications, with a postoperative distance corrected visual acuity (DCVA) \<20/20 and with postoperative refractive astigmatism \>0.50 D were also excluded.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vivity Patients n=30 Participants The study included patients \>40 years old that underwent routine cataract surgery and IOL implantation. Exclusion criteria included corneal astigmatism ≥1.0 diopters (D), amblyopia, previous ocular surgery, and presence of ocular pathologies and abnormal iris. Patients with intra- or postoperative complications, with a postoperative distance corrected visual acuity (DCVA) \<20/20 and with postoperative refractive astigmatism \>0.50 D were also excluded.
Age, Continuous	69.37 years STANDARD_DEVIATION 7.10 • n=30 Participants
Sex: Female, Male Female	19 Participants n=30 Participants
Sex: Female, Male Male	11 Participants n=30 Participants

PRIMARY outcome

Timeframe: Three months after surgery

Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x0\*, taking as a reference the subjects' axis

Outcome measures

Outcome measures
Measure	Vivity Patients n=30 Participants The study included patients \>40 years old that underwent routine cataract surgery and IOL implantation. Exclusion criteria included corneal astigmatism ≥1.0 diopters (D), amblyopia, previous ocular surgery, and presence of ocular pathologies and abnormal iris. Patients with intra- or postoperative complications, with a postoperative distance corrected visual acuity (DCVA) \<20/20 and with postoperative refractive astigmatism \>0.50 D were also excluded.
Distance Against the Rule Astimatism	0.01 LogMAR Standard Deviation 0.04

PRIMARY outcome

Timeframe: Three months after surgery

Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x45\*, taking as a reference the subjects' axis

Outcome measures

Outcome measures
Measure	Vivity Patients n=30 Participants The study included patients \>40 years old that underwent routine cataract surgery and IOL implantation. Exclusion criteria included corneal astigmatism ≥1.0 diopters (D), amblyopia, previous ocular surgery, and presence of ocular pathologies and abnormal iris. Patients with intra- or postoperative complications, with a postoperative distance corrected visual acuity (DCVA) \<20/20 and with postoperative refractive astigmatism \>0.50 D were also excluded.
Distance Oblique Astigmatism	0.01 LogMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: Three months after surgery

Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x90\*, taking as a reference the subjects' axis

Outcome measures

Outcome measures
Measure	Vivity Patients n=30 Participants The study included patients \>40 years old that underwent routine cataract surgery and IOL implantation. Exclusion criteria included corneal astigmatism ≥1.0 diopters (D), amblyopia, previous ocular surgery, and presence of ocular pathologies and abnormal iris. Patients with intra- or postoperative complications, with a postoperative distance corrected visual acuity (DCVA) \<20/20 and with postoperative refractive astigmatism \>0.50 D were also excluded.
Distance With the Rule Astigmatism	0.01 LogMAR Standard Deviation 0.05

Adverse Events

Vivity Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Inés Contreras

Clínica Rementería

Phone: 34913083838

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place