Clinical Investigation of Expanded Designs of a Multifocal IOL

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Completed
CT.gov ID
NCT01714635
Collaborator
(none)
445
Enrollment
18
Locations
3
Arms
19.9
Duration (Months)
24.7
Patients Per Site
1.2
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Fishkind, Bakewell & Maltzman Eye Care & Surgery CenterTucsonArizonaUnited States85704
2Boozman-Hof Regional Eye ClinicRogersArkansasUnited States72757
3Empire Eye & Laser CenterBakersfieldCaliforniaUnited States93309
4Assil Eye InstituteBeverly HillsCaliforniaUnited States90210
5Cape Coral Eye Center (Argus Research Center)Cape CoralFloridaUnited States33904
6Virdi Eye Clinic & Laser Vision CenterRock IslandIllinoisUnited States61201
7Eye Surgeons of IndianaIndianapolisIndianaUnited States46256
8Wallace Eye SurgeryAlexandriaLouisianaUnited States71303
9Pepose Vision InstituteChesterfieldMissouriUnited States63017
10Ophthalmic Consultants of Long IslandRockville CenterNew YorkUnited States11570
11The Eye Center of Central PAAllenwoodPennsylvaniaUnited States17810
12Scott & Christie and Associates, PCCranberry TownshipPennsylvaniaUnited States16066
13Bucci Cataract & Laser VisionWilkes BarrePennsylvaniaUnited States18702
14Loden Vision CenterGoodlettsvilleTennesseeUnited States37072
15Whitsett Vision GroupHoustonTexasUnited States77055
16Lone Star Eye CareSugar LandTexasUnited States77479
17Clarus Eye CentreLaceyWashingtonUnited States98503
18The Midline Eye InstituteSolihullUnited KingdomB91 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 TitleTecnis Multifocal Intraocular Lens #1Tecnis Multifocal Intraocular Lens #2Monofocal Intraocular Lens
Arm/Group DescriptionA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensCommercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens
Period Title: Overall Study
STARTED147150148
COMPLETED145150146
NOT COMPLETED202

Baseline Characteristics

Arm/Group TitleTecnis Multifocal Intraocular Lens #1Tecnis Multifocal Intraocular Lens #2Monofocal Intraocular LensTotal
Arm/Group DescriptionA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensCommercially available monofocal intraocular lens (IOL) Monofocal Intraocular LensTotal of all reporting groups
Overall Participants147150148445
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
TitleMean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm
DescriptionMean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative
Time Framesix months

Outcome Measure Data

Analysis Population Description
eyes
Arm/Group TitleTecnis Multifocal Intraocular Lens #1Tecnis Multifocal Intraocular Lens #2Monofocal Intraocular Lens
Arm/Group DescriptionA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensCommercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens
Measure Participants147150148
Mean (Standard Deviation) [LogMAR VA]
0.253
(0.012)
0.179
(0.011)
0.582
(0.014)
2. Secondary Outcome
TitleMean Diopter Range With VA of 20/40 or Better
DescriptionMean 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 Framesix months

Outcome Measure Data

Analysis Population Description
eyes
Arm/Group TitleTecnis Multifocal Intraocular Lens #1Tecnis Multifocal Intraocular Lens #2Monofocal Intraocular Lens
Arm/Group DescriptionA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensCommercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens
Measure Participants596361
Mean (Standard Deviation) [diopters]
3.16
(0.50)
3.30
(0.69)
1.75
(0.70)
3. Secondary Outcome
TitleSpectacle Independence
DescriptionNumber of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.
Time Framesix 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 TitleTecnis Multifocal Intraocular Lens #1Tecnis Multifocal Intraocular Lens #2Monofocal Intraocular Lens
Arm/Group DescriptionA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensCommercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens
Measure Participants142149145
Number [participants]
87
59.2%
111
74%
3
2%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleTecnis Multifocal Intraocular Lens #1Tecnis Multifocal Intraocular Lens #2Monofocal Intraocular Lens
Arm/Group DescriptionA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensA low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular LensCommercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens
All Cause Mortality
Tecnis Multifocal Intraocular Lens #1Tecnis Multifocal Intraocular Lens #2Monofocal Intraocular Lens
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN)
Serious Adverse Events
Tecnis Multifocal Intraocular Lens #1Tecnis Multifocal Intraocular Lens #2Monofocal Intraocular Lens
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/147 (1.4%) 8/150 (5.3%) 3/148 (2%)
Eye disorders
Secondary surgical intervention - not lens-related0/147 (0%) 04/150 (2.7%) 51/148 (0.7%) 1
Secondary surgical intervention - lens-related0/147 (0%) 01/150 (0.7%) 10/148 (0%) 0
Orbital fracture0/147 (0%) 01/150 (0.7%) 10/148 (0%) 0
Central retinal artery occlusion0/147 (0%) 01/150 (0.7%) 10/148 (0%) 0
Endophthalmitis/hypopyon0/147 (0%) 01/150 (0.7%) 10/148 (0%) 0
Cystoid macular edema2/147 (1.4%) 20/150 (0%) 02/148 (1.4%) 4
Other (Not Including Serious) Adverse Events
Tecnis Multifocal Intraocular Lens #1Tecnis Multifocal Intraocular Lens #2Monofocal Intraocular Lens
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/147 (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/TitleKendra Hileman, Ph.D., Director, Clinical Research & Development
OrganizationAbbott Medical Optics
Phone714-247-8613
Emailkendra.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