Trial Outcomes & Findings for Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism (NCT NCT01852084)
NCT ID: NCT01852084
Last Updated: 2020-09-16
Results Overview
Dioptric change in cylinder from the preoperative keratometric cylinder magnitude to postoperative manifest refraction cylinder magnitude (referenced to the corneal plane).
COMPLETED
NA
191 participants
Baseline, Final Visit (scheduled within window: days 120-180)
2020-09-16
Participant Flow
Participant milestones
| Measure |
Control IOL
Control IOL - Spherical control lens
|
Toric IOL1.25 D
Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
|
Toric IOL 2.00 D
Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
|
Toric IOL 2.75 D
Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
79
|
80
|
20
|
12
|
|
Overall Study
COMPLETED
|
79
|
80
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism
Baseline characteristics by cohort
| Measure |
Control IOL
n=79 Participants
Control IOL - Spherical control lens
|
Toric IOL1.25 D
n=80 Participants
Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
|
Toric IOL 2.00 D
n=20 Participants
Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
|
Toric IOL 2.75 D
n=12 Participants
Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 8.6 • n=93 Participants
|
71.1 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
68.7 years
STANDARD_DEVIATION 9.1 • n=27 Participants
|
69.6 years
STANDARD_DEVIATION 8.8 • n=483 Participants
|
70.1 years
STANDARD_DEVIATION 8.7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
102 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
89 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, Final Visit (scheduled within window: days 120-180)Population: Evaluable participants at the specified timepoint are included in the analysis.
Dioptric change in cylinder from the preoperative keratometric cylinder magnitude to postoperative manifest refraction cylinder magnitude (referenced to the corneal plane).
Outcome measures
| Measure |
Control IOL
n=78 Participants
Control IOL - Spherical control lens
|
Toric IOL1.25 D
n=80 Participants
Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
|
Toric IOL 2.00 D
n=18 Participants
Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
|
Toric IOL 2.75 D
n=12 Participants
Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
|
|---|---|---|---|---|
|
Mean Dioptric Change in Cylinder
|
-0.479 diopter
Standard Deviation 0.665
|
-0.865 diopter
Standard Deviation 0.487
|
-1.413 diopter
Standard Deviation 0.532
|
-1.944 diopter
Standard Deviation 0.327
|
PRIMARY outcome
Timeframe: Form 3 Visit (window: days 30-60), Final Visit (window: days 120-180)Population: The measure was not assessed for the control IOL. Evaluable participants at the specified timepoint are included in the analysis.
Intraocular Lens (IOL) rotation of less than or equal to five degrees between Forms 3 (scheduled within window: days 30-60) and final visit (scheduled within window: days 120-180).
Outcome measures
| Measure |
Control IOL
Control IOL - Spherical control lens
|
Toric IOL1.25 D
n=74 Participants
Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
|
Toric IOL 2.00 D
n=15 Participants
Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
|
Toric IOL 2.75 D
n=12 Participants
Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
|
|---|---|---|---|---|
|
Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees
|
—
|
74 Participants
|
15 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Final Visit (scheduled within window: days 120-180)Population: Evaluable participants at the specified timepoint are included in the analysis.
Best-corrected distance visual acuity (BCDVA) at Final Visit, expressed as logarithm of the minimum angle of resolution (logMAR). Corrected means spectacle corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity.
Outcome measures
| Measure |
Control IOL
n=78 Participants
Control IOL - Spherical control lens
|
Toric IOL1.25 D
n=80 Participants
Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
|
Toric IOL 2.00 D
n=18 Participants
Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
|
Toric IOL 2.75 D
n=12 Participants
Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
|
|---|---|---|---|---|
|
Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit
|
0.01 logMAR
Standard Deviation 0.09
|
0.00 logMAR
Standard Deviation 0.09
|
0.05 logMAR
Standard Deviation 0.10
|
-0.01 logMAR
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Final Visit (scheduled within window: days 120-180)Population: Evaluable participants at the specified timepoint are included in the analysis.
Outcome measures
| Measure |
Control IOL
n=78 Participants
Control IOL - Spherical control lens
|
Toric IOL1.25 D
n=80 Participants
Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
|
Toric IOL 2.00 D
n=18 Participants
Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
|
Toric IOL 2.75 D
n=12 Participants
Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
|
|---|---|---|---|---|
|
Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended.
Within 0.50 D of intended
|
27 Participants
|
43 Participants
|
12 Participants
|
8 Participants
|
|
Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended.
Within 1.00 D of intended
|
45 Participants
|
71 Participants
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Final Visit (scheduled within window: days 120-180)Population: Evaluable participants at the specified timepoint are included in the analysis.
Uncorrected distance visual acuity (UCDVA), expressed as logarithm of the minimum angle of resolution (logMAR). Uncorrected means not spectacle-corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity.
Outcome measures
| Measure |
Control IOL
n=78 Participants
Control IOL - Spherical control lens
|
Toric IOL1.25 D
n=80 Participants
Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
|
Toric IOL 2.00 D
n=18 Participants
Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
|
Toric IOL 2.75 D
n=12 Participants
Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
|
|---|---|---|---|---|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit
|
0.19 logMAR
Standard Deviation 0.16
|
0.11 logMAR
Standard Deviation 0.14
|
0.12 logMAR
Standard Deviation 0.11
|
0.13 logMAR
Standard Deviation 0.18
|
Adverse Events
Control IOL
Toric IOL1.25 D
Toric IOL 2.00 D
Toric IOL 2.75 D
Serious adverse events
| Measure |
Control IOL
n=79 participants at risk
Control IOL - Spherical control lens
|
Toric IOL1.25 D
n=80 participants at risk
Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
|
Toric IOL 2.00 D
n=20 participants at risk
Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
|
Toric IOL 2.75 D
n=12 participants at risk
Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
|
|---|---|---|---|---|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/79 • 180 days
|
0.00%
0/80 • 180 days
|
5.0%
1/20 • 180 days
|
0.00%
0/12 • 180 days
|
|
Eye disorders
IOL tilt
|
0.00%
0/79 • 180 days
|
1.2%
1/80 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/12 • 180 days
|
|
Eye disorders
Anterior lens vault
|
0.00%
0/79 • 180 days
|
1.2%
1/80 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/12 • 180 days
|
Other adverse events
| Measure |
Control IOL
n=79 participants at risk
Control IOL - Spherical control lens
|
Toric IOL1.25 D
n=80 participants at risk
Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)
|
Toric IOL 2.00 D
n=20 participants at risk
Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)
|
Toric IOL 2.75 D
n=12 participants at risk
Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
|
|---|---|---|---|---|
|
Eye disorders
Corneal edema
|
19.0%
15/79 • 180 days
|
22.5%
18/80 • 180 days
|
15.0%
3/20 • 180 days
|
0.00%
0/12 • 180 days
|
|
Eye disorders
Anterior chamber cell
|
21.5%
17/79 • 180 days
|
18.8%
15/80 • 180 days
|
5.0%
1/20 • 180 days
|
8.3%
1/12 • 180 days
|
|
Eye disorders
Anterior chamber flare
|
5.1%
4/79 • 180 days
|
3.8%
3/80 • 180 days
|
5.0%
1/20 • 180 days
|
8.3%
1/12 • 180 days
|
|
Eye disorders
Punctate keratosis
|
7.6%
6/79 • 180 days
|
6.2%
5/80 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/12 • 180 days
|
|
Eye disorders
Visual acuity reduced
|
8.9%
7/79 • 180 days
|
2.5%
2/80 • 180 days
|
5.0%
1/20 • 180 days
|
8.3%
1/12 • 180 days
|
|
Eye disorders
Dry eye
|
1.3%
1/79 • 180 days
|
1.2%
1/80 • 180 days
|
10.0%
2/20 • 180 days
|
0.00%
0/12 • 180 days
|
|
Eye disorders
Diplopia
|
0.00%
0/79 • 180 days
|
1.2%
1/80 • 180 days
|
5.0%
1/20 • 180 days
|
0.00%
0/12 • 180 days
|
|
Eye disorders
Trichiasis
|
0.00%
0/79 • 180 days
|
1.2%
1/80 • 180 days
|
5.0%
1/20 • 180 days
|
0.00%
0/12 • 180 days
|
|
Eye disorders
Maculopathy
|
0.00%
0/79 • 180 days
|
0.00%
0/80 • 180 days
|
5.0%
1/20 • 180 days
|
0.00%
0/12 • 180 days
|
|
Eye disorders
Photophobia
|
0.00%
0/79 • 180 days
|
0.00%
0/80 • 180 days
|
5.0%
1/20 • 180 days
|
0.00%
0/12 • 180 days
|
|
Investigations
Intraocular pressure increased
|
3.8%
3/79 • 180 days
|
6.2%
5/80 • 180 days
|
5.0%
1/20 • 180 days
|
0.00%
0/12 • 180 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER