Clinical trial NCT03949335: Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
Official title: Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Corneal Astigmatism
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-14
Enrollment: 272
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens group) at 6 months. After informed consent is obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated according to randomization.

After signing the informed consent form, subjects meeting all eligibility criteria will be randomized in a masked fashion to a treatment group: either the investigational IOL Model ZFR00V or the control IOL Model ZCB00. Prior to randomization, the investigator will choose which eye to operate on first for each subject at his/her discretion based on his/her standard clinical practice (e.g., the eye with the worse cataract, poorer best corrected distance vision and/or more severe optical/visual complaints). All subjects are intended to have bilateral cataract surgery with the second eye surgery occurring after the 1-week postoperative exam for the first eye, but no more than 30 days after the first eye surgery. All subjects will be examined through 6 months postoperatively according to the visit schedule


Eligibility criteria: Inclusion Criteria:

* be at least 22 years old
* have cataracts in both eyes
* sign the written informed consent
* be willing and able to comply with examination procedures
* understand, read and write English to complete informed consent and questionnaires
* be available for study follow-up visits

Exclusion Criteria:

* currently participating in any other clinical study or have participated in a clinical study during the last 60 days
* have a certain disease/illness such as poorly-controlled diabetes
* have certain ocular conditions such as uncontrolled glaucoma
* Is taking medication that may affect vision
* Subject is pregnant, plan to become pregnant during the study, or is breastfeeding

Primary outcomes:
measure: Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm
timeFrame: 6 months (postoperative)
Secondary outcomes:
measure: Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm
timeFrame: 6 months (postoperative)
measure: Monocular Distance-Corrected Near Visual Acuity at 33 cm
timeFrame: 6 months postoperative
measure: Monocular Photopic Best-Corrected Distance Visual Acuity
timeFrame: 6 months postoperative
measure: Monocular Distance-Corrected Defocus Curve
timeFrame: 6 months postoperative
measure: Spectacle Wear
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: West Palm Beach
country: United States
facility: Katzen Eye Care & Laser Center
state: Florida
city: Sioux City
country: United States
facility: Jones Eye Clinic
state: Iowa
city: Annapolis
country: United States
facility: Chesapeake Eye Care & Laser Center
state: Maryland
city: Blue Ash
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Carolina EyeCare Physicians
state: South Carolina
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: Houston
country: United States
facility: Berkeley Eye Institute
state: Texas
city: Hurst
country: United States
facility: Texas Eye and Laser Center
state: Texas
city: Nacogdoches
country: United States
facility: Lehmann Eye Center
state: Texas
city: San Antonio
country: United States
facility: Focal Point Vision
state: Texas
city: Lacey
country: United States
facility: Clarus Eye Centre
state: Washington
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References: