Clinical Investigation of Expanded Designs of a Multifocal IOL

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Completed
CT.gov ID
NCT01714635
Collaborator
(none)
445
18
3
19.9
24.7
1.2

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
  • Device: Tecnis Multifocal Intraocular Lens
  • Device: Monofocal Intraocular Lens
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
445 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Jul 1, 2014

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

  1. 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

  1. 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.

  2. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01714635
Other Study ID Numbers:
  • DIOL-106-ZMLA
First Posted:
Oct 26, 2012
Last Update Posted:
Mar 17, 2015
Last Verified:
Nov 1, 2014
Keywords provided by Abbott Medical Optics
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Secondary Outcome
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)
3. Secondary Outcome
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

[Not Specified]

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
Email kendra.hileman@amo.abbott.com
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01714635
Other Study ID Numbers:
  • DIOL-106-ZMLA
First Posted:
Oct 26, 2012
Last Update Posted:
Mar 17, 2015
Last Verified:
Nov 1, 2014