Clinical Investigation of Expanded Designs of a Multifocal IOL
Study Details
Study Description
Brief Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Tecnis Multifocal Intraocular lens #1 A low diopter add multifocal intraocular lens |
Device: Tecnis Multifocal Intraocular Lens
|
Experimental: Tecnis Multifocal Intraocular Lens #2 A low diopter add multifocal intraocular lens |
Device: Tecnis Multifocal Intraocular Lens
|
Active Comparator: Monofocal Intraocular Lens Commercially available monofocal intraocular lens (IOL) |
Device: Monofocal Intraocular Lens
|
Outcome Measures
Primary Outcome Measures
- Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm [six months]
Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative
Secondary Outcome Measures
- Mean Diopter Range With VA of 20/40 or Better [six months]
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.
- Spectacle Independence [six months]
Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Minimum 18 years of age
-
Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
-
Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 or worse (Snellen) with or without a glare source
-
Potential for postoperative best-corrected visual acuity of 20/25 or better
-
Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and no irregular corneal astigmatism
-
Clear intraocular media, other than cataract
-
Availability, willingness and sufficient cognitive awareness to comply with examination procedures
-
Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
-
Ability to understand and respond to a questionnaire verbally administered in English
Exclusion Criteria:
-
Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D
-
Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
-
Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes
-
Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
-
Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study
-
Inability to achieve keratometric stability for contact lens wearers
-
Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study
-
Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
-
Use of systemic or ocular medications that may affect vision
-
Prior, current, or anticipated use during the course of the 12-month study of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery
-
Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
-
Poorly-controlled diabetes
-
Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: ocular hypertension without glaucomatous changes is acceptable.
-
Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
-
Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
-
Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial
-
Desire for monovision correction
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fishkind, Bakewell & Maltzman Eye Care & Surgery Center | Tucson | Arizona | United States | 85704 |
2 | Boozman-Hof Regional Eye Clinic | Rogers | Arkansas | United States | 72757 |
3 | Empire Eye & Laser Center | Bakersfield | California | United States | 93309 |
4 | Assil Eye Institute | Beverly Hills | California | United States | 90210 |
5 | Cape Coral Eye Center (Argus Research Center) | Cape Coral | Florida | United States | 33904 |
6 | Virdi Eye Clinic & Laser Vision Center | Rock Island | Illinois | United States | 61201 |
7 | Eye Surgeons of Indiana | Indianapolis | Indiana | United States | 46256 |
8 | Wallace Eye Surgery | Alexandria | Louisiana | United States | 71303 |
9 | Pepose Vision Institute | Chesterfield | Missouri | United States | 63017 |
10 | Ophthalmic Consultants of Long Island | Rockville Center | New York | United States | 11570 |
11 | The Eye Center of Central PA | Allenwood | Pennsylvania | United States | 17810 |
12 | Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | United States | 16066 |
13 | Bucci Cataract & Laser Vision | Wilkes Barre | Pennsylvania | United States | 18702 |
14 | Loden Vision Center | Goodlettsville | Tennessee | United States | 37072 |
15 | Whitsett Vision Group | Houston | Texas | United States | 77055 |
16 | Lone Star Eye Care | Sugar Land | Texas | United States | 77479 |
17 | Clarus Eye Centre | Lacey | Washington | United States | 98503 |
18 | The Midline Eye Institute | Solihull | United Kingdom | B91 2AW |
Sponsors and Collaborators
- Abbott Medical Optics
Investigators
- Study Director: Kendra Hileman, PhD, Abbott Medical Optics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DIOL-106-ZMLA
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Tecnis Multifocal Intraocular Lens #1 | Tecnis Multifocal Intraocular Lens #2 | Monofocal Intraocular Lens |
---|---|---|---|
Arm/Group Description | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | Commercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens |
Period Title: Overall Study | |||
STARTED | 147 | 150 | 148 |
COMPLETED | 145 | 150 | 146 |
NOT COMPLETED | 2 | 0 | 2 |
Baseline Characteristics
Arm/Group Title | Tecnis Multifocal Intraocular Lens #1 | Tecnis Multifocal Intraocular Lens #2 | Monofocal Intraocular Lens | Total |
---|---|---|---|---|
Arm/Group Description | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | Commercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens | Total of all reporting groups |
Overall Participants | 147 | 150 | 148 | 445 |
Age, Customized (participants) [Number] | ||||
Less than 60 years |
21
14.3%
|
18
12%
|
13
8.8%
|
52
11.7%
|
60 - 69 years |
58
39.5%
|
68
45.3%
|
67
45.3%
|
193
43.4%
|
70 - 79 years |
66
44.9%
|
59
39.3%
|
60
40.5%
|
185
41.6%
|
Greater than or equal to 80 years |
2
1.4%
|
5
3.3%
|
8
5.4%
|
15
3.4%
|
Not reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | ||||
Female |
74
50.3%
|
101
67.3%
|
85
57.4%
|
260
58.4%
|
Male |
73
49.7%
|
49
32.7%
|
63
42.6%
|
185
41.6%
|
Region of Enrollment (participants) [Number] | ||||
United States |
146
99.3%
|
150
100%
|
147
99.3%
|
443
99.6%
|
United Kingdom |
1
0.7%
|
0
0%
|
1
0.7%
|
2
0.4%
|
Outcome Measures
Title | Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm |
---|---|
Description | Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative |
Time Frame | six months |
Outcome Measure Data
Analysis Population Description |
---|
eyes |
Arm/Group Title | Tecnis Multifocal Intraocular Lens #1 | Tecnis Multifocal Intraocular Lens #2 | Monofocal Intraocular Lens |
---|---|---|---|
Arm/Group Description | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | Commercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens |
Measure Participants | 147 | 150 | 148 |
Mean (Standard Deviation) [LogMAR VA] |
0.253
(0.012)
|
0.179
(0.011)
|
0.582
(0.014)
|
Title | Mean Diopter Range With VA of 20/40 or Better |
---|---|
Description | 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. |
Time Frame | six months |
Outcome Measure Data
Analysis Population Description |
---|
eyes |
Arm/Group Title | Tecnis Multifocal Intraocular Lens #1 | Tecnis Multifocal Intraocular Lens #2 | Monofocal Intraocular Lens |
---|---|---|---|
Arm/Group Description | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | Commercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens |
Measure Participants | 59 | 63 | 61 |
Mean (Standard Deviation) [diopters] |
3.16
(0.50)
|
3.30
(0.69)
|
1.75
(0.70)
|
Title | Spectacle Independence |
---|---|
Description | Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone. |
Time Frame | six months |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Tecnis Multifocal Intraocular Lens #1 | Tecnis Multifocal Intraocular Lens #2 | Monofocal Intraocular Lens |
---|---|---|---|
Arm/Group Description | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | Commercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens |
Measure Participants | 142 | 149 | 145 |
Number [participants] |
87
59.2%
|
111
74%
|
3
2%
|
Adverse Events
Time Frame | ||||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Tecnis Multifocal Intraocular Lens #1 | Tecnis Multifocal Intraocular Lens #2 | Monofocal Intraocular Lens | |||
Arm/Group Description | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | Commercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens | |||
All Cause Mortality |
||||||
Tecnis Multifocal Intraocular Lens #1 | Tecnis Multifocal Intraocular Lens #2 | Monofocal Intraocular Lens | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Tecnis Multifocal Intraocular Lens #1 | Tecnis Multifocal Intraocular Lens #2 | Monofocal Intraocular Lens | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/147 (1.4%) | 8/150 (5.3%) | 3/148 (2%) | |||
Eye disorders | ||||||
Secondary surgical intervention - not lens-related | 0/147 (0%) | 0 | 4/150 (2.7%) | 5 | 1/148 (0.7%) | 1 |
Secondary surgical intervention - lens-related | 0/147 (0%) | 0 | 1/150 (0.7%) | 1 | 0/148 (0%) | 0 |
Orbital fracture | 0/147 (0%) | 0 | 1/150 (0.7%) | 1 | 0/148 (0%) | 0 |
Central retinal artery occlusion | 0/147 (0%) | 0 | 1/150 (0.7%) | 1 | 0/148 (0%) | 0 |
Endophthalmitis/hypopyon | 0/147 (0%) | 0 | 1/150 (0.7%) | 1 | 0/148 (0%) | 0 |
Cystoid macular edema | 2/147 (1.4%) | 2 | 0/150 (0%) | 0 | 2/148 (1.4%) | 4 |
Other (Not Including Serious) Adverse Events |
||||||
Tecnis Multifocal Intraocular Lens #1 | Tecnis Multifocal Intraocular Lens #2 | Monofocal Intraocular Lens | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/147 (0%) | 0/150 (0%) | 0/148 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
After the trial is completed, investigators must obtain approval from AMO in writing prior to disclosing trial results.
Results Point of Contact
Name/Title | Kendra Hileman, Ph.D., Director, Clinical Research & Development |
---|---|
Organization | Abbott Medical Optics |
Phone | 714-247-8613 |
kendra.hileman@amo.abbott.com |
- DIOL-106-ZMLA