Trial Outcomes & Findings for Clinical Investigation of Expanded Designs of a Multifocal IOL (NCT NCT01714635)
NCT ID: NCT01714635
Last Updated: 2015-03-17
Results Overview
Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
445 participants
Primary outcome timeframe
six months
Results posted on
2015-03-17
Participant Flow
Participant milestones
| Measure |
Tecnis Multifocal Intraocular Lens #1
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Tecnis Multifocal Intraocular Lens #2
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Monofocal Intraocular Lens
Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens
|
|---|---|---|---|
|
Overall Study
STARTED
|
147
|
150
|
148
|
|
Overall Study
COMPLETED
|
145
|
150
|
146
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
Tecnis Multifocal Intraocular Lens #1
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Tecnis Multifocal Intraocular Lens #2
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Monofocal Intraocular Lens
Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens
|
|---|---|---|---|
|
Overall Study
Discontinued
|
1
|
0
|
2
|
|
Overall Study
Missed 6-month exam
|
1
|
0
|
0
|
Baseline Characteristics
Clinical Investigation of Expanded Designs of a Multifocal IOL
Baseline characteristics by cohort
| Measure |
Tecnis Multifocal Intraocular Lens #1
n=147 Participants
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Tecnis Multifocal Intraocular Lens #2
n=150 Participants
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Monofocal Intraocular Lens
n=148 Participants
Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens
|
Total
n=445 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Less than 60 years
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
13 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Age, Customized
60 - 69 years
|
58 participants
n=5 Participants
|
68 participants
n=7 Participants
|
67 participants
n=5 Participants
|
193 participants
n=4 Participants
|
|
Age, Customized
70 - 79 years
|
66 participants
n=5 Participants
|
59 participants
n=7 Participants
|
60 participants
n=5 Participants
|
185 participants
n=4 Participants
|
|
Age, Customized
Greater than or equal to 80 years
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Age, Customized
Not reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
260 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
146 participants
n=5 Participants
|
150 participants
n=7 Participants
|
147 participants
n=5 Participants
|
443 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: six monthsPopulation: eyes
Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative
Outcome measures
| Measure |
Tecnis Multifocal Intraocular Lens #1
n=147 Participants
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Tecnis Multifocal Intraocular Lens #2
n=150 Participants
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Monofocal Intraocular Lens
n=148 Participants
Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens
|
|---|---|---|---|
|
Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm
|
0.253 LogMAR VA
Standard Deviation 0.012
|
0.179 LogMAR VA
Standard Deviation 0.011
|
0.582 LogMAR VA
Standard Deviation 0.014
|
SECONDARY outcome
Timeframe: six monthsPopulation: eyes
Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately\*) to reach the 6-month visit were included in the substudy. \* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.
Outcome measures
| Measure |
Tecnis Multifocal Intraocular Lens #1
n=59 Participants
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Tecnis Multifocal Intraocular Lens #2
n=63 Participants
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Monofocal Intraocular Lens
n=61 Participants
Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens
|
|---|---|---|---|
|
Mean Diopter Range With VA of 20/40 or Better
|
3.16 diopters
Standard Deviation 0.50
|
3.30 diopters
Standard Deviation 0.69
|
1.75 diopters
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: six monthsPopulation: Five subjects (3 from Group #1 \[145-142\], 1 from Group #2 \[150-149\], and 1 from the monofocal control group \[146-145\]) did not complete the questionnaire because they were unavailable, refused to complete it, implant status precluded completion (bilateral implants required), or failed to answer this particular question.
Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.
Outcome measures
| Measure |
Tecnis Multifocal Intraocular Lens #1
n=142 Participants
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Tecnis Multifocal Intraocular Lens #2
n=149 Participants
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Monofocal Intraocular Lens
n=145 Participants
Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens
|
|---|---|---|---|
|
Spectacle Independence
|
87 participants
|
111 participants
|
3 participants
|
Adverse Events
Tecnis Multifocal Intraocular Lens #1
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Tecnis Multifocal Intraocular Lens #2
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Monofocal Intraocular Lens
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tecnis Multifocal Intraocular Lens #1
n=147 participants at risk
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Tecnis Multifocal Intraocular Lens #2
n=150 participants at risk
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
|
Monofocal Intraocular Lens
n=148 participants at risk
Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens
|
|---|---|---|---|
|
Eye disorders
Secondary surgical intervention - not lens-related
|
0.00%
0/147
|
2.7%
4/150 • Number of events 5
|
0.68%
1/148 • Number of events 1
|
|
Eye disorders
Secondary surgical intervention - lens-related
|
0.00%
0/147
|
0.67%
1/150 • Number of events 1
|
0.00%
0/148
|
|
Eye disorders
Orbital fracture
|
0.00%
0/147
|
0.67%
1/150 • Number of events 1
|
0.00%
0/148
|
|
Eye disorders
Central retinal artery occlusion
|
0.00%
0/147
|
0.67%
1/150 • Number of events 1
|
0.00%
0/148
|
|
Eye disorders
Endophthalmitis/hypopyon
|
0.00%
0/147
|
0.67%
1/150 • Number of events 1
|
0.00%
0/148
|
|
Eye disorders
Cystoid macular edema
|
1.4%
2/147 • Number of events 2
|
0.00%
0/150
|
1.4%
2/148 • Number of events 4
|
Other adverse events
Adverse event data not reported
Additional Information
Kendra Hileman, Ph.D., Director, Clinical Research & Development
Abbott Medical Optics
Phone: 714-247-8613
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After the trial is completed, investigators must obtain approval from AMO in writing prior to disclosing trial results.
- Publication restrictions are in place
Restriction type: OTHER