Trial Outcomes & Findings for Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses (NCT NCT05075746)
NCT ID: NCT05075746
Last Updated: 2024-03-27
Results Overview
Reduction in the cylindrical power of the eye is defined as the difference between the magnitudes of the preoperative keratometric cylinder and the residual refractive cylinder (referenced to the corneal plane).
Recruitment status
COMPLETED
Target enrollment
302 participants
Primary outcome timeframe
4 weeks after IOL implantation
Results posted on
2024-03-27
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
enVista Toric 0.9D Intra Ocular Lens
enVista Toric: enVista Toric IOL
|
enVista Non-Toric (Spherical) Intra Ocular Lens
enVista non-Toric (spherical): enVista non-Toric (spherical) IOL
|
|---|---|---|
|
Overall Study
STARTED
|
157 192
|
145 191
|
|
Overall Study
COMPLETED
|
157 192
|
145 191
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses
Baseline characteristics by cohort
| Measure |
enVista Toric 0.9D Intra Ocular Lens
n=192 Eyes
enVista Toric: enVista Toric IOL
|
enVista Non-Toric (Spherical) Intra Ocular Lens
n=191 Eyes
enVista non-Toric (spherical): enVista non-Toric (spherical) IOL
|
Total
n=383 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 8.73 • n=14 Eyes
|
72.5 years
STANDARD_DEVIATION 8.44 • n=23 Eyes
|
71.6 years
STANDARD_DEVIATION 8.63 • n=50 Eyes
|
|
Sex: Female, Male
Female
|
112 Eyes
n=14 Eyes
|
96 Eyes
n=23 Eyes
|
208 Eyes
n=50 Eyes
|
|
Sex: Female, Male
Male
|
80 Eyes
n=14 Eyes
|
95 Eyes
n=23 Eyes
|
175 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Asian
|
24 Eyes
n=14 Eyes
|
25 Eyes
n=23 Eyes
|
49 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Black or African American
|
5 Eyes
n=14 Eyes
|
4 Eyes
n=23 Eyes
|
9 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
White
|
99 Eyes
n=14 Eyes
|
96 Eyes
n=23 Eyes
|
195 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
More than one race
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
64 Eyes
n=14 Eyes
|
66 Eyes
n=23 Eyes
|
130 Eyes
n=50 Eyes
|
|
Region of Enrollment
Canada
|
192 Eyes
n=14 Eyes
|
191 Eyes
n=23 Eyes
|
383 Eyes
n=50 Eyes
|
PRIMARY outcome
Timeframe: 4 weeks after IOL implantationReduction in the cylindrical power of the eye is defined as the difference between the magnitudes of the preoperative keratometric cylinder and the residual refractive cylinder (referenced to the corneal plane).
Outcome measures
| Measure |
enVista Toric 0.9D Intra Ocular Lens
n=192 Eyes
enVista Toric: enVista Toric IOL
|
enVista Non-Toric (Spherical) Intra Ocular Lens
n=191 Eyes
enVista non-Toric (spherical): enVista non-Toric (spherical) IOL
|
|---|---|---|
|
Mean Reduction in Cylindrical Power of the Eye
|
0.432 Diopters
Standard Deviation 0.4468
|
0.071 Diopters
Standard Deviation 0.4073
|
Adverse Events
enVista Toric 0.9D Intra Ocular Lens
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
enVista Non-Toric (Spherical) Intra Ocular Lens
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
enVista Toric 0.9D Intra Ocular Lens
n=157 participants at risk
enVista Toric: enVista Toric IOL
|
enVista Non-Toric (Spherical) Intra Ocular Lens
n=145 participants at risk
enVista non-Toric (spherical): enVista non-Toric (spherical) IOL
|
|---|---|---|
|
Eye disorders
Posterior Capsule Opafication
|
16.6%
26/157 • Number of events 31 • 4 weeks after IOL implantation
|
6.2%
9/145 • Number of events 13 • 4 weeks after IOL implantation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor for details.
- Publication restrictions are in place
Restriction type: OTHER