Clinical Investigation of the Next-Generation Intraocular Lens

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Completed
CT.gov ID
NCT03111550
Collaborator
(none)
242
Enrollment
12
Locations
3
Arms
9.5
Actual Duration (Months)
20.2
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL.

The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00
  • Device: Investigational Intraocular Lens Device #2: TECNIS Model ZQR00
  • Device: TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
subject/evaluator-masked
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
Actual Study Start Date :
May 10, 2017
Actual Primary Completion Date :
Feb 23, 2018
Actual Study Completion Date :
Feb 23, 2018

Arms and Interventions

ArmIntervention/Treatment
Other: Investigational Lens Device #1

Investigational Intraocular Lens Device #1: Tecnis Model ZHR00

Device: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00
Intraocular lens replaces the natural lens removed during cataract surgery.

Other: Investigational Lens Device #2

Investigational Intraocular Lens Device #2: Tecnis Model ZQR00

Device: Investigational Intraocular Lens Device #2: TECNIS Model ZQR00
Intraocular lens replaces the natural lens removed during cataract surgery.

Other: Control Device

Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00

Device: TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
Intraocular lens replaces the natural lens removed during cataract surgery.

Outcome Measures

Primary Outcome Measures

  1. Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm [1 month postoperative]

    The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative

  2. Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) [6 months postoperative]

    Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). ISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. SPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US). Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.

  3. Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) [6 months postoperative]

    Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution. Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Bilateral cataracts

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

  • Corneal astigmatism of 1.00 D or less in both eyes

  • Normal corneal topography

  • Clear intraocular media other than cataract in each eye

  • Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries

Exclusion Criteria:
  • 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

  • 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

  • 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

  • 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 of tamsulosin or silodosin

  • Poorly-controlled diabetes

  • Acute, chronic, or uncontrolled systemic or ocular disease or illness

  • Known ocular disease or pathology that may affect visual acuity or may require surgical intervention during the course of the study or may be expected to require retinal laser treatment or other surgical intervention during the course of the study

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

  • Desire for monovision correction

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Empire Eye and Laser CenterBakersfieldCaliforniaUnited States93309
2Assil Eye InstituteBeverly HillsCaliforniaUnited States90210
3Jones Eye CareSioux CityIowaUnited States51104
4Chesapeake Eye Care and LaserAnnapolisMarylandUnited States21401
5Eye Doctors of WashingtonChevy ChaseMarylandUnited States20815
6Ophthalmology Consultants LTDSaint LouisMissouriUnited States63131
7Scott and Christie and Associates,PCCranberry TownshipPennsylvaniaUnited States16066
8Carolina Cataract and Laser CenterLadsonSouth CarolinaUnited States29456
9Vance Thompson VisionSioux FallsSouth DakotaUnited States57108
10Loden Vision CentersGoodlettsvilleTennesseeUnited States37072
11Key-Whitman Eye CenterDallasTexasUnited States75243
12Texas Eye and Laser CenterHurstTexasUnited States76054

Sponsors and Collaborators

  • Abbott Medical Optics

Investigators

  • Study Director: Devi Priya Janakiraman, OD,FAAO, Abbott Medical Optics

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT03111550
Other Study ID Numbers:
  • EDOF-121-NGPC
First Posted:
Apr 13, 2017
Last Update Posted:
Aug 24, 2020
Last Verified:
Aug 1, 2020
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 DetailA total of 242 subjects were enrolled in this study, and 229 subjects were implanted with study IOL in first eye.
Arm/Group TitleTecnis ZHR00Tecnis ZQR00Tecnis ZXR00
Arm/Group DescriptionInvestigational Lens DeviceInvestigational Lens DeviceControl Lens Device
Period Title: Overall Study
STARTED777379
COMPLETED737176
NOT COMPLETED423

Baseline Characteristics

Arm/Group TitleTecnis ZHR00Tecnis ZQR00Tecnis ZXR00Total
Arm/Group DescriptionInvestigational Lens DeviceInvestigational Lens DeviceControl Lens DeviceTotal of all reporting groups
Overall Participants777379229
Age, Customized (Number) [Number]
Les than < 60 years
10
13%
11
15.1%
7
8.9%
28
12.2%
60-69 years
37
48.1%
34
46.6%
44
55.7%
115
50.2%
70-79 years
29
37.7%
24
32.9%
27
34.2%
80
34.9%
Greater than or equal to >= 80 years
1
1.3%
4
5.5%
1
1.3%
6
2.6%
Not reported
0
0%
0
0%
0
0%
0
0%
Sex: Female, Male (Count of Participants)
Female
48
62.3%
47
64.4%
46
58.2%
141
61.6%
Male
29
37.7%
26
35.6%
33
41.8%
88
38.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
1
1.3%
2
2.7%
2
2.5%
5
2.2%
Not Hispanic or Latino
76
98.7%
71
97.3%
77
97.5%
224
97.8%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Race/Ethnicity, Customized (Number) [Number]
Asian (including Indian)
3
3.9%
2
2.7%
1
1.3%
6
2.6%
Black
2
2.6%
2
2.7%
5
6.3%
9
3.9%
Native Hawaiian/Pacific Islander
0
0%
0
0%
0
0%
0
0%
Caucasian
71
92.2%
69
94.5%
73
92.4%
213
93%
Other race
1
1.3%
0
0%
0
0%
1
0.4%
Not Reported
0
0%
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
TitleMonocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
DescriptionThe primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative
Time Frame1 month postoperative

Outcome Measure Data

Analysis Population Description
The safety population (SP) of all subjects implanted who have available data will be used for all analysis. For the monocular endpoints, the safety population will consist of first eyes implanted with a study IOL.
Arm/Group TitleTecnis ZHR00Tecnis ZQR00Tecnis ZXR00
Arm/Group DescriptionInvestigational Lens DeviceInvestigational Lens DeviceControl Lens Device
Measure Participants767278
Measure Eyes767278
Mean (Standard Deviation) [LogMAR]
0.136
(0.120)
0.141
(0.149)
0.276
(0.116)
2. Primary Outcome
TitleRates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)
DescriptionAdverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). ISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. SPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US). Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.
Time Frame6 months postoperative

Outcome Measure Data

Analysis Population Description
Statistical comparisons to ISO SPE rates are based on first-eye data
Arm/Group TitleTecnis ZHR00Tecnis ZQR00Tecnis ZXR00
Arm/Group DescriptionInvestigational Lens DeviceInvestigational Lens DeviceControl Lens Device
Measure Participants737176
Corneal edema
0.0
0.0
1.3
Cystoid macular edema
0.0
0.0
0.0
Iritis
0.0
0.0
0.0
Raised IOP requiring treatment
0.0
0.0
0.0
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tecnis ZXR00
Comments
Type of Statistical Test Superiority
Comments Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for corneal edema)
Statistical Test of Hypothesisp-Value0.02041
Comments
MethodExact test on binomial distribution
Comments
3. Primary Outcome
TitleRates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)
DescriptionAdverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution. Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.
Time Frame6 months postoperative

Outcome Measure Data

Analysis Population Description
Statistical comparisons to ISO SPE rates are based on first-eye data
Arm/Group TitleTecnis ZHR00Tecnis ZQR00Tecnis ZXR00
Arm/Group DescriptionInvestigational Lens DeviceInvestigational Lens DeviceControl Lens Device
Measure Participants777379
Cystoid Macular Edema
0.0
0.0
1.3
Hypopyon
0.0
0.0
0.0
Endolphthalmitis
0.0
0.0
0.0
Lens dislocated from posterior chamber
0.0
0.0
0.0
Pupillary block
0.0
0.0
0.0
Retinal detachment
0.0
1.4
0.0
Eyes with secondary surgical intervention
1.3
4.1
1.3
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tecnis ZQR00
Comments
Type of Statistical Test Superiority
Comments Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for retinal detachment)
Statistical Test of Hypothesisp-Value0.1969
CommentsFor ZQR00 retinal detachment
MethodExact test on binomial distribution
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tecnis ZHR00
Comments
Type of Statistical Test Superiority
Comments Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)
Statistical Test of Hypothesisp-Value0.4655
CommentsFor ZHR00 secondary surgical intervention
MethodExact test of binomial distribution
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tecnis ZQR00
Comments
Type of Statistical Test Superiority
Comments Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)
Statistical Test of Hypothesisp-Value0.0210
CommentsFor ZQR00 secondary surgical intention
MethodExact test on binomial distribution
Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tecnis ZXR00
Comments
Type of Statistical Test Superiority
Comments Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)
Statistical Test of Hypothesisp-Value0.4698
CommentsFor ZXR00 secondary surgical intervention
MethodExact test on binomial distribution
Comments

Adverse Events

Time Frame6 months
Adverse Event Reporting Description The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group. One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
Arm/Group TitleTecnis ZHR00ZQR00ZXR00
Arm/Group DescriptionInvestigational Lens DeviceInvestigational Lens DeviceControl Lens Device
All Cause Mortality
Tecnis ZHR00ZQR00ZXR00
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/78 (2.6%) 0/73 (0%) 1/79 (1.3%)
Serious Adverse Events
Tecnis ZHR00ZQR00ZXR00
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total8/78 (10.3%) 7/73 (9.6%) 5/79 (6.3%)
Cardiac disorders
Heart Attack1/78 (1.3%) 10/73 (0%) 00/79 (0%) 0
Eye disorders
Retinal tear and repair0/78 (0%) 01/73 (1.4%) 10/79 (0%) 0
Cystoid Macular Edema0/78 (0%) 00/73 (0%) 01/79 (1.3%) 2
Retinal Detachment0/78 (0%) 01/73 (1.4%) 10/79 (0%) 0
Lens removal due to undesired optical phenomena due to fixed pupil0/78 (0%) 01/73 (1.4%) 10/79 (0%) 0
Gastrointestinal disorders
Diverticulitis of Large intestine with perforation resulting in hospitalization1/78 (1.3%) 10/73 (0%) 00/79 (0%) 0
General disorders
Death during sleep1/78 (1.3%) 10/73 (0%) 00/79 (0%) 0
Injury, poisoning and procedural complications
Hospitalization due to hip fracture secondary to fall1/78 (1.3%) 10/73 (0%) 00/79 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer0/78 (0%) 01/73 (1.4%) 10/79 (0%) 0
Hospitalization due to surgical removal of tumors1/78 (1.3%) 10/73 (0%) 00/79 (0%) 0
Death secondary to cancer1/78 (1.3%) 10/73 (0%) 01/79 (1.3%) 1
Hospitalization due to weakness secondary to cancer0/78 (0%) 00/73 (0%) 01/79 (1.3%) 1
Product Issues
Secondary Surgical Intervention: IOL removal1/78 (1.3%) 11/73 (1.4%) 21/79 (1.3%) 2
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease0/78 (0%) 01/73 (1.4%) 10/79 (0%) 0
Surgical and medical procedures
Hernia Surgical repair1/78 (1.3%) 10/73 (0%) 00/79 (0%) 0
Hospitalization due to cholecystectomy0/78 (0%) 01/73 (1.4%) 10/79 (0%) 0
Vascular disorders
Blood Clot in leg requiring emergency angioplasty0/78 (0%) 00/73 (0%) 01/79 (1.3%) 1
Other (Not Including Serious) Adverse Events
Tecnis ZHR00ZQR00ZXR00
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total4/78 (5.1%) 3/73 (4.1%) 3/79 (3.8%)
Product Issues
ADE, Bothersome visual symptoms causing significant impairment lasting more than 3 mos postop4/78 (5.1%) 43/73 (4.1%) 33/79 (3.8%) 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/TitleDevi Priya Janakiraman,OD, FAAO
OrganizationJohnson & Johnson Surgical Vision
Phone+1 714-247-8628
Emaildjanaki1@its.jnj.com
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT03111550
Other Study ID Numbers:
  • EDOF-121-NGPC
First Posted:
Apr 13, 2017
Last Update Posted:
Aug 24, 2020
Last Verified:
Aug 1, 2020