Trial Outcomes & Findings for Investigation of the Safety and Effectiveness of Monofocal Toric Intraocular Lens (IOL) (NCT NCT06399211)
NCT ID: NCT06399211
Last Updated: 2026-04-22
Results Overview
Intraocular lens (IOL) axis misalignment of less than 10 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery
Recruitment status
COMPLETED
Target enrollment
261 participants
Primary outcome timeframe
Form 4 visit (window: 120-180 days)
Results posted on
2026-04-22
Participant Flow
Subjects were recruited from 9 investigative sites located in the United States.
Of the 261 enrolled, 31 exited as screen failures prior to randomization. A total of 230 participants were randomized in a ratio of 1:1 to receive either the PODEYE TORIC Intraocular lens (IOL) or the AcrySof SA60AT Monofocal IOL (control) in the study eye (unilaterally). 5 participants discontinued after randomization but before implantation. A total of 225 participants were implanted unilaterally with either PODEYE TORIC IOL or the control IOL.
Participant milestones
| Measure |
PODEYE TORIC IOL (1.5 D)
Cataractous lens was removed in the study eye and the PODEYE TORIC IOL (1.5 D) was implanted in the capsular bag.
|
Control IOL
Cataractous lens was removed in the study eye and the control IOL was implanted in the capsular bag.
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
115
|
|
Overall Study
COMPLETED
|
111
|
112
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
Baseline characteristics by cohort
| Measure |
Control IOL
n=113 Participants
Cataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag.
|
Total
n=225 Participants
Total of all reporting groups
|
PODEYE TORIC IOL (1.5 D)
n=112 Participants
Cataractous lens was removed in the study eye and the PODEYE TORIC IOL (1.5 D) was implanted in the capsular bag.
|
|---|---|---|---|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 9.65 • n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
69.0 years
STANDARD_DEVIATION 8.74 • n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
69.7 years
STANDARD_DEVIATION 7.69 • n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Sex: Female, Male
Female
|
71 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
137 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
66 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Sex: Female, Male
Male
|
42 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
88 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
46 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
3 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
3 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
5 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
4 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
1 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
0 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
3 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
2 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Race (NIH/OMB)
White
|
110 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
212 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
102 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
1 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
1 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
0 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
0 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
4 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
3 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
221 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
109 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
0 Participants
n=116 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
0 Participants
n=60 Participants • Of the 115 subjects randomized to each group, 112 in the Treatment group and 113 in the Control group were treated.
|
PRIMARY outcome
Timeframe: Form 4 visit (window: 120-180 days)Residual Cylinder in Diopters as measured by Manifest Refraction
Outcome measures
| Measure |
PODEYE TORIC IOL (1.5 D)
n=111 Participants
Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.
|
Control IOL
n=112 Participants
Cataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag.
|
|---|---|---|
|
Mean Residual Manifest Cylinder in Diopters in Toric and Control Arms.
|
-0.286 Diopters
Interval -0.3448 to -0.2273
|
-0.813 Diopters
Interval -0.9214 to -0.7036
|
PRIMARY outcome
Timeframe: Form 4 visit (window: 120-180 days)Intraocular lens (IOL) axis misalignment of less than 10 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery
Outcome measures
| Measure |
PODEYE TORIC IOL (1.5 D)
n=115 Participants
Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.
|
Control IOL
Cataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag.
|
|---|---|---|
|
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than 10 Degrees (Toric IOL Arm Only)
|
115 Participants
|
—
|
PRIMARY outcome
Timeframe: Form 4 visit (window: 120-180 days)Intraocular lens (IOL) axis misalignment of less than 20 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery
Outcome measures
| Measure |
PODEYE TORIC IOL (1.5 D)
n=115 Participants
Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.
|
Control IOL
Cataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag.
|
|---|---|---|
|
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than 20 Degrees (Toric IOL Arm Only)
|
115 Participants
|
—
|
PRIMARY outcome
Timeframe: Form 3 Visit (window: 30-60 days), Form 4 Visit (window: 120-180 days)Intraocular Lens (IOL) rotation of less than or equal to five degrees between Form 3 visit (window: 30-60 days) and Form 4 visit (window: 120-180 days)
Outcome measures
| Measure |
PODEYE TORIC IOL (1.5 D)
n=115 Participants
Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.
|
Control IOL
Cataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag.
|
|---|---|---|
|
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than or Equal to 5 Degrees (Toric IOL Arm Only)
|
115 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Form 4 Visit (window: 120-180 days)Secondary surgical interventions (SSIs) related to the optical properties of the IOL including IOL rotation SSIs for misalignment.
Outcome measures
| Measure |
PODEYE TORIC IOL (1.5 D)
n=112 Participants
Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.
|
Control IOL
n=113 Participants
Cataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag.
|
|---|---|---|
|
Rate of Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL.
|
0 number of events
Interval 0.0 to 0.03
|
0 number of events
Interval 0.0 to 0.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Form 4 Visit (window: 120-180 days)Rates of cumulative and persistent Adverse Events via comparison to the ISO Safety and Performance Endpoint (SPE) rates as described in ISO 11979-7
Outcome measures
| Measure |
PODEYE TORIC IOL (1.5 D)
n=112 Participants
Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.
|
Control IOL
n=113 Participants
Cataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag.
|
|---|---|---|
|
Rates of Cumulative and Persistent Adverse Events.
Cumulative: Hypopyon
|
0 Number of events
|
0 Number of events
|
|
Rates of Cumulative and Persistent Adverse Events.
Cumulative: Endophthalmitis
|
0 Number of events
|
0 Number of events
|
|
Rates of Cumulative and Persistent Adverse Events.
Cumulative: Lens dislocated from posterior chamber
|
0 Number of events
|
0 Number of events
|
|
Rates of Cumulative and Persistent Adverse Events.
Cumulative: Pupillary block
|
0 Number of events
|
0 Number of events
|
|
Rates of Cumulative and Persistent Adverse Events.
Cumulative: Retinal Detachment
|
1 Number of events
|
0 Number of events
|
|
Rates of Cumulative and Persistent Adverse Events.
Cumulative:Secondary surgical intervention
|
1 Number of events
|
1 Number of events
|
|
Rates of Cumulative and Persistent Adverse Events.
Persistent: Corneal stroma oedema
|
0 Number of events
|
0 Number of events
|
|
Rates of Cumulative and Persistent Adverse Events.
Persistent: Cystoid macular oedema
|
0 Number of events
|
0 Number of events
|
|
Rates of Cumulative and Persistent Adverse Events.
Persistent: Iritis
|
0 Number of events
|
1 Number of events
|
|
Rates of Cumulative and Persistent Adverse Events.
Persistent: Raised IOP requiring treatment
|
0 Number of events
|
0 Number of events
|
|
Rates of Cumulative and Persistent Adverse Events.
Cumulative: Cystoid macular edema
|
0 Number of events
|
0 Number of events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Form 4 Visit (window: 120-180 days)Proportion of eyes achieving best-corrected distance visual acuity (BCDVA) of 0.30 logMAR or better at Form 4. BCDVA was measured at 4 meters using an ETDRS chart under photopic conditions. A logMAR value of 0.3 or better (lower logMAR = better vision) corresponds to approximately 20/40 Snellen acuity. The performance goal was at least 92.5% per ISO 11979-7:2018 Table E.3 for All-Implanted eyes and 96.7% per Table E.4 for Best-Case eyes.
Outcome measures
| Measure |
PODEYE TORIC IOL (1.5 D)
n=111 Participants
Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.
|
Control IOL
n=112 Participants
Cataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag.
|
|---|---|---|
|
Number of Participants With Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better
|
111 Participants
|
112 Participants
|
Adverse Events
PODEYE Toric IOL - Study Eye
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Alcon AcrySof SA60AT Monofocal Study Eye
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
PODEYE Toric IOL - Systemic
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcon AcrySof SA60AT Monofocal -Systemic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PODEYE Toric IOL - Study Eye
n=112 participants at risk
Operated Eyes with PODEYE TORIC IOL
|
Alcon AcrySof SA60AT Monofocal Study Eye
n=113 participants at risk
Eyes operated with Monofocal control IOL
|
PODEYE Toric IOL - Systemic
n=112 participants at risk
Eyes implanted with PODEYE Toric IOL
|
Alcon AcrySof SA60AT Monofocal -Systemic
n=113 participants at risk
Eyes implanted with Control Monofocal
|
|---|---|---|---|---|
|
Eye disorders
Retinal Tear
|
0.00%
0/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.88%
1/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.89%
1/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
|
Infections and infestations
Urethritis
|
0.00%
0/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.89%
1/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
|
Surgical and medical procedures
Eye operation
|
0.89%
1/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.88%
1/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
Other adverse events
| Measure |
PODEYE Toric IOL - Study Eye
n=112 participants at risk
Operated Eyes with PODEYE TORIC IOL
|
Alcon AcrySof SA60AT Monofocal Study Eye
n=113 participants at risk
Eyes operated with Monofocal control IOL
|
PODEYE Toric IOL - Systemic
n=112 participants at risk
Eyes implanted with PODEYE Toric IOL
|
Alcon AcrySof SA60AT Monofocal -Systemic
n=113 participants at risk
Eyes implanted with Control Monofocal
|
|---|---|---|---|---|
|
Investigations
Intraocular pressure increased
|
3.6%
4/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
9.7%
11/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
|
Eye disorders
Corneal oedema
|
6.2%
7/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
9.7%
11/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
|
Eye disorders
Iridocyclitis
|
29.5%
33/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
48.7%
55/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/112 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
0.00%
0/113 • Implantation through study completion, up to 6 months
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place