Clinical Investigation of the Next-Generation Intraocular Lenses

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Completed
CT.gov ID
NCT03372434
Collaborator
(none)
225
Enrollment
12
Locations
3
Arms
9.4
Actual Duration (Months)
18.8
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL.

The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 260 subjects to achieve approximately 220 randomized and bilaterally-implanted subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 65 in the control group) at 1 and 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL. The eye implanted first will be considered the primary study eye.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Investigational Intraocular Lens Device #1: Model ZFR00
  • Device: Investigational Intraocular Lens Device #1: Model ZYR00
  • Device: TECNIS Multifocal Intraocular Lens: Model ZLB00
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
Actual Study Start Date :
Jan 16, 2018
Actual Primary Completion Date :
Jul 11, 2018
Actual Study Completion Date :
Oct 30, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: Investigational Lens Device #1

Investigational Intraocular Lens Device #1: Model ZFR00

Device: Investigational Intraocular Lens Device #1: Model ZFR00
IOL replaces the natural lens removed during cataract surgery.

Experimental: Investigational Lens Device #2

Investigational Intraocular Lens Device #1: Model ZYR00

Device: Investigational Intraocular Lens Device #1: Model ZYR00
IOL replaces the natural lens removed during cataract surgery.

Active Comparator: Control Device

Control TECNIS Multifocal Intraocular Lens Model ZLB00

Device: TECNIS Multifocal Intraocular Lens: Model ZLB00
IOL replaces the natural lens removed during cataract surgery.

Outcome Measures

Primary Outcome Measures

  1. Distance Corrected Intermediate Visual Acuity [1 month]

    Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Minimum 22 years of age

  • Bilateral cataracts for which posterior chamber IOL implantation has been planned

  • Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with a glare source or 20/40 Snellen or worse without a glare source

  • Potential for postoperative BCDVA of 20/30 Snellen or better

  • Corneal astigmatism:

  • Normal corneal topography

  • Preoperative corneal astigmatism of 1.00 D or less in both eyes

  • Clear intraocular media other than cataract in each eye

  • 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 in English

Exclusion Criteria:
  • Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D

  • Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils)

  • Irregular corneal astigmatism

  • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)

  • Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery. Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcome or increase risk to the subject, are acceptable.

  • Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study

  • Inability to achieve keratometric stability for contact lens wearers (per procedure outlined in Section 10.3)

  • Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject

  • 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 worse than 20/30 Snellen during the study

  • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as 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 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)

  • 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 outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.

  • Known ocular disease or pathology that, in the opinion of the investigator,

  • may affect visual acuity

  • may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)

  • 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 60 days prior to preoperative visit in any other clinical trial

  • Desire for monovision correction

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Empire Eye & Laser CenterBakersfieldCaliforniaUnited States93309
2Katzen Eye Care and Laser CenterBoynton BeachFloridaUnited States33426
3Chesapeake Eye Care & Laser CenterAnnapolisMarylandUnited States21401
4Eye Doctors of WashingtonChevy ChaseMarylandUnited States20815
5Scott & Christie and Associates, PCCranberry TownshipPennsylvaniaUnited States16066
6Carolina EyeCare Physicians, LLCMount PleasantSouth CarolinaUnited States29464
7Loden Vision CentersGoodlettsvilleTennesseeUnited States37072
8Eye Specialty GroupMemphisTennesseeUnited States38120
9Texas Eye and Laser CenterHurstTexasUnited States76054
10Lehmann Eye CenterNacogdochesTexasUnited States75965
11Focal Point VisionSan AntonioTexasUnited States78209
12Clarus Eye CentreLaceyWashingtonUnited States98503

Sponsors and Collaborators

  • Abbott Medical Optics

Investigators

  • Study Director: Abbott Medical Optics Clinical Trials, Abbott Medical Optics

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT03372434
Other Study ID Numbers:
  • SUR-CAT-652-1001
First Posted:
Dec 13, 2017
Last Update Posted:
Jul 27, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail225 subjects were implanted with a study lens in at least one eye. Two hundred and twenty five (225) subjects had a study IOL in the first eye.
Arm/Group TitleModel ZFR00Model ZLB00Model ZYR00
Arm/Group DescriptionInvestigational IOL implanted in the first eyeControl IOL implanted in the first eyeInvestigational IOL implanted in the first eye
Period Title: Overall Study
STARTED787374
1 Month Follow-up767273
COMPLETED767072
NOT COMPLETED232

Baseline Characteristics

Arm/Group TitleModel ZFR00Model ZLB00Model ZYR00Total
Arm/Group DescriptionInvestigational IOL implanted in the first eyeControl IOL implanted in the first eyeInvestigational IOL implanted in the first eyeTotal of all reporting groups
Overall Participants787374225
Age, Customized (Number) [Number]
Less than <60 years
10
12.8%
13
17.8%
17
23%
40
17.8%
60-69 years
38
48.7%
35
47.9%
34
45.9%
107
47.6%
70-79 years
27
34.6%
23
31.5%
21
28.4%
71
31.6%
Greater than or equal to >/80 years
3
3.8%
2
2.7%
2
2.7%
7
3.1%
Not reported
0
0%
0
0%
0
0%
0
0%
Sex: Female, Male (Count of Participants)
Female
54
69.2%
48
65.8%
49
66.2%
151
67.1%
Male
24
30.8%
25
34.2%
25
33.8%
74
32.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
4
5.1%
6
8.2%
3
4.1%
13
5.8%
Not Hispanic or Latino
74
94.9%
67
91.8%
71
95.9%
212
94.2%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Race/Ethnicity, Customized (Number) [Number]
Asian (including Indian)
0
0%
3
4.1%
0
0%
3
1.3%
Black
3
3.8%
7
9.6%
7
9.5%
17
7.6%
Native Hawaiian/Pacific Islander
0
0%
0
0%
0
0%
0
0%
Caucasian
75
96.2%
62
84.9%
66
89.2%
203
90.2%
Another Race
0
0%
1
1.4%
0
0%
1
0.4%
Not reported
0
0%
0
0%
1
1.4%
1
0.4%

Outcome Measures

1. Primary Outcome
TitleDistance Corrected Intermediate Visual Acuity
DescriptionVisual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.
Time Frame1 month

Outcome Measure Data

Analysis Population Description
Safety population
Arm/Group TitleModel ZFR00Model ZLB00Model ZYR00
Arm/Group DescriptionInvestigational IOL implanted in the first eyeControl IOL implanted in the first eyeInvestigational IOL implanted in the first eye
Measure Participants767273
Measure Eyes767273
Mean (Standard Deviation) [LogMAR]
0.098
(0.115)
0.219
(0.146)
0.147
(0.149)

Adverse Events

Time Frame6 months
Adverse Event Reporting Description All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Arm/Group TitleModel ZFR00Model ZLB00Model ZYR00
Arm/Group DescriptionInvestigational IOL deviceControl IOL DeviceInvestigational IOL Device
All Cause Mortality
Model ZFR00Model ZLB00Model ZYR00
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/78 (0%) 0/73 (0%) 0/74 (0%)
Serious Adverse Events
Model ZFR00Model ZLB00Model ZYR00
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/78 (6.4%) 13/73 (17.8%) 4/74 (5.4%)
Blood and lymphatic system disorders
B-cell Lymphoma0/78 (0%) 01/73 (1.4%) 10/74 (0%) 0
Cardiac disorders
Patent Foramen Ovale0/78 (0%) 01/73 (1.4%) 10/74 (0%) 0
Angioplasty0/78 (0%) 01/73 (1.4%) 10/74 (0%) 0
Eye disorders
Cystoid Macular Edema0/78 (0%) 00/73 (0%) 02/74 (2.7%) 2
Macular Hole0/78 (0%) 01/73 (1.4%) 10/74 (0%) 0
Herpes Zoster Keratitis0/78 (0%) 01/73 (1.4%) 10/74 (0%) 0
Retinal Detachment1/78 (1.3%) 10/73 (0%) 00/74 (0%) 0
Haptic anterior to capsule bag0/78 (0%) 01/73 (1.4%) 10/74 (0%) 0
Increase in cells likely due to non-compliance with ocular medication regimen1/78 (1.3%) 10/73 (0%) 00/74 (0%) 0
Retinal Hole0/78 (0%) 01/73 (1.4%) 10/74 (0%) 0
General disorders
Hospitalization0/78 (0%) 03/73 (4.1%) 31/74 (1.4%) 1
Undisclosed illness requiring Hospice care0/78 (0%) 01/73 (1.4%) 10/74 (0%) 0
Infections and infestations
Shingles0/78 (0%) 01/73 (1.4%) 10/74 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer1/78 (1.3%) 11/73 (1.4%) 10/74 (0%) 0
Product Issues
Bothersome Visual Symptom1/78 (1.3%) 11/73 (1.4%) 11/74 (1.4%) 1
Visual symptoms requiring secondary surgical intervention1/78 (1.3%) 10/73 (0%) 01/74 (1.4%) 1
Other (Not Including Serious) Adverse Events
Model ZFR00Model ZLB00Model ZYR00
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total6/78 (7.7%) 1/73 (1.4%) 3/74 (4.1%)
Product Issues
Bothersome visual symptom6/78 (7.7%) 61/73 (1.4%) 13/74 (4.1%) 3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime

Results Point of Contact

Name/TitleEugenia Thomas, OD
OrganizationJohnson & Johnson Surgical Vision
Phone+1 657 2903260
EmailEThoma39@its.jnj.com
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT03372434
Other Study ID Numbers:
  • SUR-CAT-652-1001
First Posted:
Dec 13, 2017
Last Update Posted:
Jul 27, 2021
Last Verified:
Jul 1, 2021