Trial Outcomes & Findings for Performance and Acceptability of iDesign (NCT NCT01220466)
NCT ID: NCT01220466
Last Updated: 2013-05-20
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
6 months
Results posted on
2013-05-20
Participant Flow
One or both eyes of 77 subjects (143 eyes) were treated. This includes a predominance of Caucasian participants and a mean age of 37.2 years.
Participant milestones
| Measure |
Hyperopia With or Without Astigmatism
Hyperopia with and without astigmatism with MRSE up to
+9.00 D, with cylinder between 0.00 and +6.00 D.
|
Myopia With or Without Astigmatism
Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
|
Mixed Astigmatism
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
56
|
10
|
|
Overall Study
COMPLETED
|
11
|
56
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance and Acceptability of iDesign
Baseline characteristics by cohort
| Measure |
Hyperopia With or Without Astigmatism
n=11 Participants
Hyperopia with and without astigmatism with MRSE up to
+9.00 D, with cylinder between 0.00 and +6.00 D.
|
Myopia With or Without Astigmatism
n=56 Participants
Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
|
Mixed Astigmatism
n=10 Participants
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
56 participants
n=7 Participants
|
10 participants
n=5 Participants
|
77 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: UCVA is reported as percentage of eyes not percentage of subjects achieving UCVA of 20/40 or better
Outcome measures
| Measure |
Myopia With and Without Astigmatism
n=108 eyes
Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=19 eyes
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
|
Mixed Astigmatism
n=16 eyes
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.
|
100 percentage of eyes
Interval 97.3 to 100.0
|
100 percentage of eyes
Interval 85.4 to 100.0
|
100 percentage of eyes
Interval 82.9 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Percent of eyes that achieved manifest refraction spherical equivalent within 1.0 D
Outcome measures
| Measure |
Myopia With and Without Astigmatism
n=108 eyes
Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=19 eyes
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
|
Mixed Astigmatism
n=16 eyes
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D
|
99.1 percentage of eyes
Interval 94.9 to 100.0
|
89.5 percentage of eyes
Interval 66.9 to 98.7
|
93.8 percentage of eyes
Interval 69.8 to 99.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsPopulation: Percent of eyes that lost more than 2 lines of BSCVA.
Outcome measures
| Measure |
Myopia With and Without Astigmatism
n=108 eyes
Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=19 eyes
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
|
Mixed Astigmatism
n=16 eyes
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
|
0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes lost more than 2 lines of BSCVA.
|
5.3 percentage of eyes
Interval 0.1 to 26.0
|
0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes lost more than 2 lines of BSCVA.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsPopulation: Percentage of eyes with BSCVA worse than 20/40
Outcome measures
| Measure |
Myopia With and Without Astigmatism
n=108 eyes
Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=19 eyes
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
|
Mixed Astigmatism
n=16 eyes
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40
|
0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes had BSCVA worse than 20/40.
|
0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes had BSCVA worse than 20/40.
|
0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes had BSCVA worse than 20/40.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsPopulation: Percentage of eyes with induced manifest refractive astigmatism greater than 2.00 D of absolute cylinder power
Induced Manifest Refractive Astigmatism is an increase of astigmatism (cylinder) postoperatively that could be caused by the refractive treatment. An increase of greater than 2.0 D is considered a safety endpoint per ANSI Z80.11-2007.
Outcome measures
| Measure |
Myopia With and Without Astigmatism
n=108 eyes
Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=19 eyes
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
|
Mixed Astigmatism
n=16 eyes
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction
|
0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes had induced manifest refractive astigmatism greater than 2.00 D of absolute cylinder power.
|
0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes had induced manifest refractive astigmatism greater than 2.00 D of absolute cylinder power.
|
0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes had induced manifest refractive astigmatism greater than 2.00 D of absolute cylinder power.
|
Adverse Events
Hyperopia With and Without Astigmatism
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Myopia With and Without Astigmatism
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Mixed Astigmatism
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hyperopia With and Without Astigmatism
n=11 participants at risk
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
|
Myopia With and Without Astigmatism
n=56 participants at risk
Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
|
Mixed Astigmatism
n=10 participants at risk
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Eye disorders
Decrease in BSCVA of greater than or equal to two lines
|
9.1%
1/11 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
0.00%
0/10
|
Other adverse events
| Measure |
Hyperopia With and Without Astigmatism
n=11 participants at risk
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
|
Myopia With and Without Astigmatism
n=56 participants at risk
Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
|
Mixed Astigmatism
n=10 participants at risk
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Eye disorders
Corneal epithelial defect
|
9.1%
1/11 • Number of events 1
|
0.00%
0/56
|
0.00%
0/10
|
|
Eye disorders
Foreign body in the eye
|
0.00%
0/11
|
1.8%
1/56 • Number of events 1
|
0.00%
0/10
|
|
Eye disorders
Miscreated flap
|
0.00%
0/11
|
1.8%
1/56 • Number of events 1
|
0.00%
0/10
|
|
Eye disorders
retinal tear/hole
|
0.00%
0/11
|
1.8%
1/56 • Number of events 2
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Other - car accident
|
9.1%
1/11 • Number of events 1
|
0.00%
0/56
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Other - concussion
|
0.00%
0/11
|
1.8%
1/56 • Number of events 1
|
0.00%
0/10
|
Additional Information
Amelia Saliba, Sr. Manager, Clinical Research
Abbott Medical Optics
Phone: 408-273-4158
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER