Astigmatism
Conditions
Keywords
Cataract, IOL
Brief summary
The purpose of this study is to generate clinical data to quantify the impact of residual astigmatism on the overall visual performance during distance, intermediate, and near viewing in patients implanted with Clareon Vivity IOLs.
Detailed description
This single visit study is designed to help understand how vision is affected if the eye still has astigmatism after cataract surgery. Participants will be individuals who have already undergone cataract surgery and received a Clareon Vivity IOL in both eyes at least 4 months prior to study enrollment. During the study visit, trial lenses (glass lenses that are used during an eye exam) will be used to temporarily create the effect of astigmatism on the eye.
Interventions
DEVICEClareon Vivity Extended Vision IOL
Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects implanted with Clareon Vivity will be randomized to either with-the-rule (WTR) or against-the-rule (ATR) induced astigmatism first. Following the initial assessment, subjects will alternate between ATR and WTR for additional assessments based on a predefined randomization sheet.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and sign an Institution Review Board-approved informed consent form; * Willing and able to attend all scheduled study visits as required by the protocol; * Implanted with study IOLs in both eyes at least 4 months prior to study participation; * Best Corrected Distance Visual Acuity (BCDVA) of 0 logarithm minimum angle of resolution (logMAR) or better in each eye.
Exclusion criteria
* Residual astigmatism greater than or equal to 1.00 diopter (D); * Clinically significant ocular conditions as specified in the protocol; * History of ocular surgeries other than limbal relaxing incisions * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - WTR | Day 0 before induced astigmatism; Day 0 after induced astigmatism | BCDVA was assessed with best refractive correction in place at a distance of 4 meters (m) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. Trial lenses were used to induce 1.0 diopter (D) of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint. |
| Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism - WTR | Day 0 before induced astigmatism; Day 0 after induced astigmatism | DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 centimeters (cm) from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint. |
| Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - WTR | Day 0 before induced astigmatism; Day 0 after induced astigmatism | DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism WTR, defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis.VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint. |
| Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - ATR | Day 0 before induced astigmatism; Day 0 after induced astigmatism | BCDVA was assessed with best refractive correction in place at a distance of 4 m using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism against the rule (ATR), defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint. |
| Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism.- ATR | Day 0 before induced astigmatism; Day 0 after induced astigmatism | DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint. |
| Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - ATR | Day 0 before induced astigmatism; Day 0 after induced astigmatism | DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Lead, Surgical CRD
Alcon Research, LLC
Participant flow
Recruitment details
Participants were recruited from 3 investigative sites.
Pre-assignment details
Of the 40 participants who signed an Informed Consent, 6 were exited as screen failures. This reporting group includes all eligible subjects (34).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 8.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 27 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
None listed