Clinical trial NCT04890249: Clinical Investigation of Two Tecnis Investigational Lenses
Official title: Clinical Investigation of the TECNIS® Intraocular Lens, Models C1V000 and C2V000
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Corneal Astigmatism
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-18
Enrollment: 221
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a 6-month, prospective, multicenter, randomized (1:1:1), subject-masked and evaluator-masked, bilateral clinical investigation of the TECNIS IOL Models C1V000 and C2V000 versus the TECNIS Eyhance™ Model ICB00 IOL.

The study will be conducted at up to 15 sites in EU, AU, NZ and/or AP and will enroll up to 225 subjects to achieve approximately 67 bilaterally implanted subjects in each lens group. Allowing for 10% lost-to-follow-up, this will achieve approximately 60 evaluable subjects in each lens group at 1, 3, and 6 months. The eye implanted first will be considered the primary (monocular) study eye.


Eligibility criteria: Inclusion Criteria:

* Minimum 22 years of age
* Bilateral cataracts or planned natural lens removal (due to immature cataract) for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
* Cataractous lens changes, as demonstrated by best-corrected distance visual acuity (BCDVA) of 0.50 decimal or worse (6/12 or 20/40 Snellen) either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms in the opinion of the investigator
* Potential postoperative best-corrected distance visual acuity (BCDVA) of 0.66 decimal (6/9 or 20/30 Snellen) or better
* Corneal astigmatism:

  * Normal corneal topography
  * Predicted postoperative corneal astigmatism of less than 1.00 D in both eyes, including posterior corneal astigmatism (PCA)
* Clear intraocular media other than cataract
* Signed informed consent for participation in the study and data protection
* Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
* Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided.

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)
* 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
* Corneal abnormalities such as stromal, epithelial, or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study
* Irregular corneal astigmatism
* 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 (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 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 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.)
* Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation 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.

Primary outcomes:
measure: Monocular Photopic distance-corrected intermediate visual acuity
timeFrame: 6 months
measure: Monocular Photopic best-corrected distance visual acuity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Burwood
country: Australia
facility: personalEYES Pty. Ltd.
state: New South Wales
city: Chatswood
country: Australia
facility: Vision Eye Institute
state: New South Wales
city: Sydney
country: Australia
facility: George St Eye Centre
state: New South Wales
city: Sydney
country: Australia
facility: Bondi Eye Doctors
state: New South Wales
city: Waratah
country: Australia
facility: Newcastle Eye Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Eye Clinic
state: Queensland
city: South Brisbane
country: Australia
facility: Queensland Eye Institute
state: Queensland
city: Remuera
country: New Zealand
facility: Auckland Eye Ltd
state: Auckland
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References: