Clinical Investigation of the Next Generation Intraocular Lens
1 other identifier
interventional
247
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedStudy Start
First participant enrolled
June 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2019
CompletedResults Posted
Study results publicly available
June 25, 2020
CompletedJune 25, 2020
June 1, 2020
11 months
April 9, 2018
May 29, 2020
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
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.
6 months (postoperative)
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
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.
6 months (postoperative)
Secondary Outcomes (2)
Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
6 months (postoperative)
Overall Spectacle Wear
6 months (postoperative)
Study Arms (2)
Investigational Device: Next Generation TECNIS IOL
EXPERIMENTALInvestigational Intraocular Lens Device #1: Next Generation TECNIS IOL
Control Device: TECNIS Monofocal IOL
ACTIVE COMPARATORControl Monofocal Intraocular Lens: TECNIS Monofocal IOL
Interventions
Intraocular lens replaces the natural lens removed during cataract surgery.
Intraocular lens replaces the natural lens removed during cataract surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Wolstan & Goldberg Eye Associates
Torrance, California, 90505, United States
The Eye Associates of Manatee, LLP
Bradenton, Florida, 34209, United States
Levenson Eye Associates, Inc.
Jacksonville, Florida, 32204, United States
Jones Eye Clinic
Sioux City, Iowa, 51104, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Eye Care Specialists
Kingston, Pennsylvania, 18704, United States
Vance Thompson Vision Clinic, Prof LLC
Sioux Falls, South Dakota, 57108, United States
Key-Whitman Eye Center
Dallas, Texas, 11442, United States
Berkeley Eye Institute, P.A.
Houston, Texas, 77027, United States
Slade & Baker Vision
Houston, Texas, 77027, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Devi Priya Janakiraman, OD, FAAO
- Organization
- Johnson & Johnson Surgical Vision
Study Officials
- STUDY DIRECTOR
Devi Priya Janakiraman, OD, FAAO
Johnson & Johnson Surgical Vision, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2018
First Posted
April 18, 2018
Study Start
June 28, 2018
Primary Completion
June 5, 2019
Study Completion
June 5, 2019
Last Updated
June 25, 2020
Results First Posted
June 25, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share