Clinical Investigation of the Next Generation Intraocular Lens
Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03500198
Collaborator
(none)
247
10
2
11.2
24.7
2.2
Study Details
Study Description
Brief Summary
An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.
Study Design
Study Type:
Interventional
Actual Enrollment
:
247 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00
Actual Study Start Date
:
Jun 28, 2018
Actual Primary Completion Date
:
Jun 5, 2019
Actual Study Completion Date
:
Jun 5, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational Device: Next Generation TECNIS IOL Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL |
Device: Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL
Intraocular lens replaces the natural lens removed during cataract surgery.
|
| Active Comparator: Control Device: TECNIS Monofocal IOL Control Monofocal Intraocular Lens: TECNIS Monofocal IOL |
Device: Control Monofocal Intraocular Lens: TECNIS Monofocal IOL
Intraocular lens replaces the natural lens removed during cataract surgery.
|
Outcome Measures
Primary Outcome Measures
- Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) [6 months (postoperative)]
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.
- Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve [6 months (postoperative)]
Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only.
Secondary Outcome Measures
- Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm [6 months (postoperative)]
Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only.
- Overall Spectacle Wear [6 months (postoperative)]
Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of "none of the time" and the combined reports of "a little of the time," "some of the time," "most of the time," or "all of the time".
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
-
Corneal astigmatism:
-
Normal corneal topography
-
Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits
-
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:
-
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, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
-
Poorly-controlled diabetes
-
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wolstan & Goldberg Eye Associates | Torrance | California | United States | 90505 |
| 2 | The Eye Associates of Manatee, LLP | Bradenton | Florida | United States | 34209 |
| 3 | Levenson Eye Associates, Inc. | Jacksonville | Florida | United States | 32204 |
| 4 | Jones Eye Clinic | Sioux City | Iowa | United States | 51104 |
| 5 | Cincinnati Eye Institute | Cincinnati | Ohio | United States | 45242 |
| 6 | Eye Care Specialists | Kingston | Pennsylvania | United States | 18704 |
| 7 | Vance Thompson Vision Clinic, Prof LLC | Sioux Falls | South Dakota | United States | 57108 |
| 8 | Key-Whitman Eye Center | Dallas | Texas | United States | 11442 |
| 9 | Berkeley Eye Institute, P.A. | Houston | Texas | United States | 77027 |
| 10 | Slade & Baker Vision | Houston | Texas | United States | 77027 |
Sponsors and Collaborators
- Johnson & Johnson Surgical Vision, Inc.
Investigators
- Study Director: Devi Priya Janakiraman, OD, FAAO, Johnson & Johnson Surgical Vision, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT03500198
Other Study ID Numbers:
- SUR-IOL-652-2001
First Posted:
Apr 18, 2018
Last Update Posted:
Jun 25, 2020
Last Verified:
Jun 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 Detail | Total of 247 participants signed the informed consent form and out of them 27 participants were never randomized and treated, 2 were randomized but not treated. Hence 218 participants were implanted lens in the first eye, (110 in ZHR00 and 108 in ZCB00 control group). |
| Arm/Group Title | Investigational Device: ZHR00 | Control Device: ZCB00 |
|---|---|---|
| Arm/Group Description | Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. | TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. |
| Period Title: Overall Study | ||
| STARTED | 110 | 108 |
| First Eye | 110 | 108 |
| Second Eye | 109 | 108 |
| COMPLETED | 110 | 107 |
| NOT COMPLETED | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Investigational Device: ZHR00 | Control Device: ZCB00 | Total |
|---|---|---|---|
| Arm/Group Description | Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. | TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. | Total of all reporting groups |
| Overall Participants | 110 | 108 | 218 |
| Age, Customized (Number) [Number] | |||
| less than < 60 Years |
15
13.6%
|
13
12%
|
28
12.8%
|
| 60-69 Years |
49
44.5%
|
49
45.4%
|
98
45%
|
| 70-79 Years |
43
39.1%
|
40
37%
|
83
38.1%
|
| Greater than or equal to >= 80 Years |
3
2.7%
|
6
5.6%
|
9
4.1%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
71
64.5%
|
75
69.4%
|
146
67%
|
| Male |
39
35.5%
|
33
30.6%
|
72
33%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
7
6.4%
|
3
2.8%
|
10
4.6%
|
| Not Hispanic or Latino |
102
92.7%
|
105
97.2%
|
207
95%
|
| Unknown or Not Reported |
1
0.9%
|
0
0%
|
1
0.5%
|
| Race/Ethnicity, Customized (Number) [Number] | |||
| Asian (including Indian) |
4
3.6%
|
3
2.8%
|
7
3.2%
|
| Black |
6
5.5%
|
14
13%
|
20
9.2%
|
| Native Hawaiian/Pacific Islander |
0
0%
|
1
0.9%
|
1
0.5%
|
| Caucasian |
99
90%
|
90
83.3%
|
189
86.7%
|
| Other Race |
1
0.9%
|
0
0%
|
1
0.5%
|
| American Indian/Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) |
|---|---|
| Description | 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. |
| Time Frame | 6 months (postoperative) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety (SF) population included all eyes and subjects implanted in at least one eye with either a test or control IOL with data available at the time of analysis (i.e., no data imputation). Here 'N' (number of participants and number of eyes analyzed) signifies the number of participants and their first eye evaluated for this outcome measure. |
| Arm/Group Title | Investigational Device: ZHR00 | Control Device: ZCB00 |
|---|---|---|
| Arm/Group Description | Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. | TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. |
| Measure Participants | 110 | 107 |
| Measure Eyes | 110 | 107 |
| Mean (Standard Deviation) [logMAR] |
0.053
(0.149)
|
0.370
(0.173)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Investigational Device: ZHR00, Control Device: ZCB00 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve |
|---|---|
| Description | Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only. |
| Time Frame | 6 months (postoperative) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety (SF) population included all eyes and subjects implanted in at least one eye with either a test or control IOL with data available at the time of analysis (i.e., no data imputation). Here 'N' (number of participants and number of eyes analyzed) signifies the number of participants and their first eye evaluated for this outcome measure. |
| Arm/Group Title | Investigational Device: ZHR00 | Control Device: ZCB00 |
|---|---|---|
| Arm/Group Description | Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. | TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. |
| Measure Participants | 109 | 106 |
| Measure Eyes | 109 | 106 |
| Mean (Full Range) [diopter] |
2.3
|
0.8
|
| Title | Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm |
|---|---|
| Description | Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only. |
| Time Frame | 6 months (postoperative) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety (SF) population included all eyes and subjects implanted in at least one eye with either a test or control IOL with data available at the time of analysis (i.e., no data imputation). Here 'N' (number of participants and number of eyes analyzed) signifies the number of participants and their first eye evaluated for this outcome measure. |
| Arm/Group Title | Investigational Device: ZHR00 | Control Device: ZCB00 |
|---|---|---|
| Arm/Group Description | Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. | TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. |
| Measure Participants | 110 | 106 |
| Measure Eyes | 110 | 106 |
| Mean (Standard Deviation) [LogMAR] |
0.151
(0.148)
|
0.466
(0.203)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Investigational Device: ZHR00, Control Device: ZCB00 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Overall Spectacle Wear |
|---|---|
| Description | Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of "none of the time" and the combined reports of "a little of the time," "some of the time," "most of the time," or "all of the time". |
| Time Frame | 6 months (postoperative) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified intent-to-treat (mITT) population included all eyes randomized and implanted with either a test or control study intraocular lens (IOL) in the study. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Investigational Device: ZHR00 | Control Device: ZCB00 |
|---|---|---|
| Arm/Group Description | Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. | TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. |
| Measure Participants | 109 | 108 |
| Number [Percentage of participants] |
63.3
57.5%
|
7.6
7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Investigational Device: ZHR00, Control Device: ZCB00 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | 1-sided logistic regression | |
| Comments | ||
Adverse Events
| Time Frame | Up to 11.5 months | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The SF population included all eyes and participants implanted in at least one eye with either a test or control IOL with data available at the time of analysis (that is, no data imputation). Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes. | |||||||
| Arm/Group Title | Investigational Device: ZHR00 (First Eye) | Control Device: ZCB00 (First Eye) | Investigational Device: ZHR00 (Second Eye) | Control Device: ZCB00 (Second Eye) | ||||
| Arm/Group Description | Investigational next-generation tecnis symfony, model ZHR00 foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system. | Investigational next-generation tecnis control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system. | Investigational next-generation tecnis symfony, model ZHR00 foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system. | Investigational next-generation tecnis control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system. | ||||
All Cause Mortality |
||||||||
| Investigational Device: ZHR00 (First Eye) | Control Device: ZCB00 (First Eye) | Investigational Device: ZHR00 (Second Eye) | Control Device: ZCB00 (Second Eye) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/110 (0%) | 0/108 (0%) | 0/109 (0%) | 0/108 (0%) | ||||
Serious Adverse Events |
||||||||
| Investigational Device: ZHR00 (First Eye) | Control Device: ZCB00 (First Eye) | Investigational Device: ZHR00 (Second Eye) | Control Device: ZCB00 (Second Eye) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/110 (4.5%) | 5/108 (4.6%) | 6/109 (5.5%) | 4/108 (3.7%) | ||||
| Cardiac disorders | ||||||||
| Hospitalization for myocardial infarction | 1/110 (0.9%) | 1 | 1/108 (0.9%) | 1 | 1/109 (0.9%) | 1 | 1/108 (0.9%) | 1 |
| Eye disorders | ||||||||
| Retinal Detachment | 0/110 (0%) | 0 | 2/108 (1.9%) | 2 | 0/109 (0%) | 0 | 1/108 (0.9%) | 1 |
| Cystoid macular edema | 0/110 (0%) | 0 | 1/108 (0.9%) | 1 | 0/109 (0%) | 0 | 1/108 (0.9%) | 1 |
| Hypopyon | 0/110 (0%) | 0 | 0/108 (0%) | 0 | 1/109 (0.9%) | 1 | 0/108 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Hospitalization for vomiting | 1/110 (0.9%) | 1 | 0/108 (0%) | 0 | 1/109 (0.9%) | 1 | 0/108 (0%) | 0 |
| Product Issues | ||||||||
| Lens dislocation | 0/110 (0%) | 0 | 0/108 (0%) | 0 | 1/109 (0.9%) | 1 | 0/108 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Hospitalization for Pneumonia | 2/110 (1.8%) | 2 | 0/108 (0%) | 0 | 2/109 (1.8%) | 2 | 0/108 (0%) | 0 |
| Surgical and medical procedures | ||||||||
| Cortical Remnant in anterior chamber | 1/110 (0.9%) | 1 | 0/108 (0%) | 0 | 0/109 (0%) | 0 | 0/108 (0%) | 0 |
| Vascular disorders | ||||||||
| Atherosclerosis with intermittent claudication | 0/110 (0%) | 0 | 1/108 (0.9%) | 1 | 0/109 (0%) | 0 | 1/108 (0.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| Investigational Device: ZHR00 (First Eye) | Control Device: ZCB00 (First Eye) | Investigational Device: ZHR00 (Second Eye) | Control Device: ZCB00 (Second Eye) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/110 (8.2%) | 1/108 (0.9%) | 9/109 (8.3%) | 1/108 (0.9%) | ||||
| Product Issues | ||||||||
| Adverse Device Effects due to visual symptoms | 9/110 (8.2%) | 9 | 1/108 (0.9%) | 1 | 9/109 (8.3%) | 9 | 1/108 (0.9%) | 1 |
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/Title | Devi Priya Janakiraman, OD, FAAO |
|---|---|
| Organization | Johnson & Johnson Surgical Vision |
| Phone | +1 714 247- 8628 |
| djanaki1@its.jnj.com |
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT03500198
Other Study ID Numbers:
- SUR-IOL-652-2001
First Posted:
Apr 18, 2018
Last Update Posted:
Jun 25, 2020
Last Verified:
Jun 1, 2020